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| Lot Number 01-2009190 |
| Device Problems
Melted (1385); No Device Output (1435); Overheating of Device (1437); Smoking (1585); Output Problem (3005)
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| Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
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Event Type
malfunction
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Event Description
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Tof machine had been used on a patient and was left attached, but on top the blankets when staff noticed a burning smell and then smoke coming from the machine, machine was burning hot and couldn't be held (part of) battery inside had "melted" [device battery issue].Case narrative: information has been received from the agency ((b)(4)) on (b)(6) 2019.This initial spontaneous report originating from (b)(6) has been received from a (b)(6) hospital referring to an unknown patient of unknown age and gender.This report concerned 1 patient and 1 device.Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.On (b)(6) 2019, the patient used a neuromuscular transmission monitor (tof watch) for an unknown indication.The neuromuscular transmission monitor (tof watch) was left attached on top of the blankets, then, the staff noted a burning smell and a smoke that was coming from the neuromuscular transmission monitor (tof watch) which was burning hot and couldn't be held; part of the battery was "melted" (device battery issue).The neuromuscular transmission monitor (tof watch) was available for investigation.For neuromuscular transmission monitor (tof watch), the lot number was not available and the serial number was reported as (b)(4).For neuromuscular transmission monitor (tof watch), quality investigation status: this case was assessed as device reportable and an adverse event quality investigation has been initiated.
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Event Description
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Tof machine had been used on a patient and was left attached, but on top the blankets when staff noticed a burning smell and then smoke coming from the machine, machine was burning hot and couldn't be held (part of) battery inside had "melted" [device battery issue] no adverse event to patient [no adverse event] case narrative: information has been received from the agency (2018/006/011/401/019) on 11-sep-2019.This initial spontaneous report originating from united kingdom has been received from a university hospital referring to an unknown patient of unknown age and gender.This report concerned 1 patient and 1 device.Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.On (b)(6) 2018, the patient used a neuromuscular transmission monitor(tof watch) for an unknown indication.The neuromuscular transmission monitor(tof watch) was left attached on top of the blankets, then, the staff noted a burning smell and a smoke that was coming from the neuromuscular transmission monitor(tof watch) which was burning hot and couldn't be held; part of the battery was "melted" (device battery issue).The neuromuscular transmission monitor(tof watch) was available for investigation.For neuromuscular transmission monitor(tof watch), the lot number was not available and the serial number was reported as (b)(4).For neuromuscular transmission monitor(tof watch), quality investigation status: this case was assessed as device reportable and an adverse event quality investigation has been initiated.Follow up information has been received from the reporter on 18-sep-2019.It was unknown whether battery was inserted correctly.The operator of neuromuscular transmission monitor(tof watch) was a healthcare professional.The neuromuscular transmission monitor(tof watch) and battery were quarantined pending investigation.No adverse effect to patient and no ill effect.The reporter considered the event not attributable to drug but attributable to the device because the device/ battery overheated.The medical device safety officer discussed with the clinical engineer and received the following response: "i picked this up this morning and my initial thought was that the battery might have been put in upside down and the terminals shorted on the metal spring that usually supports the base of the 9 volt (v) cell.I had since spoken to the senior sister and she informed me that the event happened during use, and as far as she was aware not after a battery change, so i was disregarding the above.I could see that the battery was swollen /misshapen and it had distorted the plastic device housing.It was not possible to fit a new battery, but touching the terminals to a new battery, it seemed to work (or at least power up) could it be a battery fault.I didn't think it was high drain equipment but the battery certainly looked like it had been short circuited or been subjected to a very high current drain." the reporter considered the event no incident.
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Event Description
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Tof machine had been used on a patient and was left attached, but on top the blankets when staff noticed a burning smell and then smoke coming from the machine, machine was burning hot and couldn't be held (part of) battery inside had "melted" [device battery issue] no adverse event to patient [no adverse event] case narrative: information has been received from the agency (2018/006/011/401/019) on (b)(6) 2019.This initial spontaneous report originating from united kingdom has been received from a university hospital referring to an unknown patient of unknown age and gender.This report concerned 1 patient and 1 device.Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.On (b)(6) 2018, the patient used a neuromuscular transmission monitor(tof watch) for an unknown indication.The neuromuscular transmission monitor(tof watch) was left attached on top of the blankets, then, the staff noted a burning smell and a smoke that was coming from the neuromuscular transmission monitor(tof watch) which was burning hot and couldn't be held; part of the battery was "melted" (device battery issue).The neuromuscular transmission monitor(tof watch) was available for investigation.For neuromuscular transmission monitor(tof watch), the lot number was not available and the serial number was reported as 01-2009190.For neuromuscular transmission monitor(tof watch), quality investigation status: this case was assessed as device reportable and an adverse event quality investigation has been initiated.Follow up information has been received from the reporter on 18-sep-2019.It was unknown whether battery was inserted correctly.The operator of neuromuscular transmission monitor(tof watch) was a healthcare professional.The neuromuscular transmission monitor(tof watch) and battery were quarantined pending investigation.No adverse effect to patient and no ill effect.The reporter considered the event not attributable to drug but attributable to the device because the device/ battery overheated.The medical device safety officer discussed with the clinical engineer and received the following response: "i picked this up this morning and my initial thought was that the battery might have been put in upside down and the terminals shorted on the metal spring that usually supports the base of the 9 volt (v) cell.I had since spoken to the senior sister and she informed me that the event happened during use, and as far as she was aware not after a battery change, so i was disregarding the above.I could see that the battery was swollen /misshapen and it had distorted the plastic device housing.It was not possible to fit a new battery, but touching the terminals to a new battery, it seemed to work (or at least power up) could it be a battery fault.I didn't think it was high drain equipment but the battery certainly looked like it had been short circuited or been subjected to a very high current drain." the reporter considered the event no incident.Follow up information has been received on 17-oct-2019.Quality investigation has been completed.After several emails, still no response if the sample will be send for investigation.This record proceed without complaint sample.Executive summary as below: complaint description: from msd united kingdom we received a complaint concerning a tof watch.Tof machine had been used on a patient and left attached, but on top of the blankets when staff noticed a burning smell and then smoke coming from the machine, machine was burning hot and couldn't be held, (part of) battery inside had "melted".This concerns the first complaint for this tof watch 01-2009190.The complaint was sent for investigation to the biometer.Conclusion: investigation results :no complaint sample will be supplied, meaning that a "desk investigation" only can be conducted at biometer.Speculative potential problem(s): the forwarded description indicate that the problem relates to a very high current drain (power consumption) within the device.The high-power consumption causes generation of heat within the battery which in turn causes "burning smell "and softening (melting) of plastic within the device battery compartment above potential speculative potential problem(s) cannot be confirmed without a physical investigation of the device.Identified possible root cause(s): no "true" (correct) root-cause can be identified/ concluded as the complaint sample device is not available for investigation at biometer.Speculative potential root cause(s) for the speculative problem: ¿avery low resistance/ short-circuit /defect within the inserted 9v battery.Low resistance/ shortcircuit /defect within the battery may then have caused generation of heat, melted plastic and created burning smell.¿ a foreign object within the battery compartment may have resulted in very low resistance/ shortcircuit towards the battery contact terminals of the inserted 9v battery.Low resistance/ short-circuit towards battery terminals caused generation of heat within the battery, melted plastic and created burning smell.¿ mechanical /electrical defect in the vicinity of the battery contact terminals may have resulted in very low resistance/ short-circuit towards the inserted 9v battery.Low resistance/ short-circuit towards battery caused generation of heat within the battery, melted plastic and created burning smell ¿ an internal electrical or mechanical defect within the device could potentially also result in in a high power consumption; however; the device electrical circuit has "a fuse" ("protective element'') just following the battery contact terminals and the fuse will in such situation quickly limit possible power drain from the battery and hereby void any excessive current drain and heat generation.The internal protection fuse could potentially be defective and then in combination with another electrical/ mechanical defect result in a high current drain.Such double-fault scenario is not considered that likely but cannot be excluded ¿ other unknown mechanical /electrical defect in this 10 year old device.It is noted that this is the first time/case where the above problem/defect description has been seen/ reported over the past 22 years where approx.50.000 tof-watch devices has been marketed.It observed that the device is 10 years old and some kind of "mechanical/electrical defect'' within the device battery compartment as a result of wear/use over many years is not unlikely.Impact on other product(s) / batches: no impact expected based upon the speculative root cause, however; reliable estimation of potential impact(s) is dependent on a "true" root-cause determination.Corrective and preventive actions: no biometer corrective actions will be initiated will be initiated as a result of this complaint as: the complaint description cannot be confirmed/ verified as no complaint sample is available.Determination of "correct/true" root cause only possible if a physical investigation of the complaint sample including patient cable can be made.Preventive actions: no biometer preventive actions will be initiated as: the complaint description cannot be confirmed and verified as no sample has been supplied.Complaint report data is entered into the biometer complaint/deviation statistics.These data are reviewed at least yearly for detection of possible trends, needs for improvement etcetera.If a high number of identical complaints/deviations is detected, actions may be started.An investigation into the manufacture of lot 01-2009190 was completed and confirmed that all in-process quality checks were satisfactory.The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures.The lot was confirmed to have met the requirements for market release.Following medical review of the ae report and the quality investigation, there were no identified concerns related to quality within the results of the investigation.
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Event Description
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Tof machine had been used on a patient and was left attached, but on top the blankets when staff noticed a burning smell and then smoke coming from the machine, machine was burning hot and couldn't be held (part of) battery inside had "melted" [device battery issue].No adverse event to patient [no adverse event].Case narrative: information has been received from the agency (2018/006/011/401/019) on (b)(6) 2019.This initial spontaneous report originating from united kingdom has been received from a university hospital referring to an unknown patient of unknown age and gender.This report concerned 1 patient and 1 device.Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.On (b)(6) 2018, the patient used a neuromuscular transmission monitor(tof watch) for an unknown indication.The neuromuscular transmission monitor(tof watch) was left attached on top of the blankets, then, the staff noted a burning smell and a smoke that was coming from the neuromuscular transmission monitor(tof watch) which was burning hot and couldn't be held; part of the battery was "melted" (device battery issue).The neuromuscular transmission monitor(tof watch) was available for investigation.For neuromuscular transmission monitor(tof watch), the lot number was not available and the serial number was reported as 01-2009190.For neuromuscular transmission monitor(tof watch), quality investigation status: this case was assessed as device reportable and an adverse event quality investigation has been initiated.Follow up information has been received from the reporter on (b)(6) 2019.It was unknown whether battery was inserted correctly.The operator of neuromuscular transmission monitor(tof watch) was a healthcare professional.The neuromuscular transmission monitor(tof watch) and battery were quarantined pending investigation.No adverse effect to patient and no ill effect.The reporter considered the event not attributable to drug but attributable to the device because the device/ battery overheated.The medical device safety officer discussed with the clinical engineer and received the following response: "i picked this up this morning and my initial thought was that the battery might have been put in upside down and the terminals shorted on the metal spring that usually supports the base of the 9 volt (v) cell.I had since spoken to the senior sister and she informed me that the event happened during use, and as far as she was aware not after a battery change, so i was disregarding the above.I could see that the battery was swollen /misshapen and it had distorted the plastic device housing.It was not possible to fit a new battery, but touching the terminals to a new battery, it seemed to work (or at least power up) could it be a battery fault.I didn't think it was high drain equipment but the battery certainly looked like it had been short circuited or been subjected to a very high current drain." the reporter considered the event no incident.Follow up information has been received on 17-oct-2019.Quality investigation has been completed.After several emails, still no response if the sample will be send for investigation.This record proceed without complaint sample.Executive summary as below: complaint description: from msd united kingdom we received a complaint concerning a tof watch.Tof machine had been used on a patient and left attached, but on top of the blankets when staff noticed a burning smell and then smoke coming from the machine, machine was burning hot and couldn't be held, (part of) battery inside had "melted".This concerns the first complaint for this tof watch 01-2009190.The complaint was sent for investigation to the biometer.Conclusion: investigation results :no complaint sample will be supplied, meaning that a "desk investigation" only can be conducted at biometer.Speculative potential problem(s): the forwarded description indicate that the problem relates to a very high current drain (power consumption) within the device.The high-power consumption causes generation of heat within the battery which in turn causes "burning smell "and softening (melting) of plastic within the device battery compartment above potential speculative potential problem(s) cannot be confirmed without a physical investigation of the device.Identified possible root cause(s): no "true" (correct) root-cause can be identified/ concluded as the complaint sample device is not available for investigation at biometer.Speculative potential root cause(s) for the speculative problem: ¿avery low resistance/ short-circuit /defect within the inserted 9v battery.Low resistance/ shortcircuit /defect within the battery may then have caused generation of heat, melted plastic and created burning smell.¿ a foreign object within the battery compartment may have resulted in very low resistance/ shortcircuit towards the battery contact terminals of the inserted 9v battery.Low resistance/ short-circuit towards battery terminals caused generation of heat within the battery, melted plastic and created burning smell.¿ mechanical /electrical defect in the vicinity of the battery contact terminals may have resulted in very low resistance/ short-circuit towards the inserted 9v battery.Low resistance/ short-circuit towards battery caused generation of heat within the battery, melted plastic and created burning smell ¿ an internal electrical or mechanical defect within the device could potentially also result in in a high power consumption; however; the device electrical circuit has "a fuse" ("protective element'') just following the battery contact terminals and the fuse will in such situation quickly limit possible power drain from the battery and hereby void any excessive current drain and heat generation.The internal protection fuse could potentially be defective and then in combination with another electrical/ mechanical defect result in a high current drain.Such double-fault scenario is not considered that likely but cannot be excluded ¿ other unknown mechanical /electrical defect in this 10 year old device.It is noted that this is the first time/case where the above problem/defect description has been seen/ reported over the past 22 years where approx.50.000 tof-watch devices has been marketed.It observed that the device is 10 years old and some kind of "mechanical/electrical defect'' within the device battery compartment as a result of wear/use over many years is not unlikely.Impact on other product(s) / batches: no impact expected based upon the speculative root cause, however; reliable estimation of potential impact(s) is dependent on a "true" root-cause determination.Corrective and preventive actions: no biometer corrective actions will be initiated will be initiated as a result of this complaint as: the complaint description cannot be confirmed/ verified as no complaint sample is available.Determination of "correct/true" root cause only possible if a physical investigation of the complaint sample including patient cable can be made.Preventive actions: no biometer preventive actions will be initiated as: the complaint description cannot be confirmed and verified as no sample has been supplied.Complaint report data is entered into the biometer complaint/deviation statistics.These data are reviewed at least yearly for detection of possible trends, needs for improvement etcetera.If a high number of identical complaints/deviations is detected, actions may be started.
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Manufacturer Narrative
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Adverse event quality investigation has been completed.
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Event Description
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Tof machine had been used on a patient and was left attached, but on top the blankets when staff noticed a burning smell and then smoke coming from the machine, machine was burning hot and couldn't be held (part of) battery inside had "melted" [device battery issue.No adverse event to patient [no adverse event.Case narrative: information has been received from the agency (2018/006/011/401/019) on 11-sep-2019.This initial spontaneous report originating from united kingdom has been received from a university hospital referring to an unknown patient of unknown age and gender.This report concerned 1 patient and 1 device.Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.On (b)(6) 2018, the patient used a neuromuscular transmission monitor(tof watch) for an unknown indication.The neuromuscular transmission monitor(tof watch) was left attached on top of the blankets, then, the staff noted a burning smell and a smoke that was coming from the neuromuscular transmission monitor(tof watch) which was burning hot and couldn't be held; part of the battery was "melted" (device battery issue).The neuromuscular transmission monitor(tof watch) was available for investigation.For neuromuscular transmission monitor(tof watch), the lot number was not available and the serial number was reported as (b)(4).For neuromuscular transmission monitor(tof watch), quality investigation status: this case was assessed as device reportable and an adverse event quality investigation has been initiated.Follow up information has been received from the reporter on 18-sep-2019.It was unknown whether battery was inserted correctly.The operator of neuromuscular transmission monitor(tof watch) was a healthcare professional.The neuromuscular transmission monitor(tof watch) and battery were quarantined pending investigation.No adverse effect to patient and no ill effect.The reporter considered the event not attributable to drug but attributable to the device because the device/ battery overheated.The medical device safety officer discussed with the clinical engineer and received the following response: "i picked this up this morning and my initial thought was that the battery might have been put in upside down and the terminals shorted on the metal spring that usually supports the base of the 9 volt (v) cell.I had since spoken to the senior sister and she informed me that the event happened during use, and as far as she was aware not after a battery change, so i was disregarding the above.I could see that the battery was swollen /misshapen and it had distorted the plastic device housing.It was not possible to fit a new battery, but touching the terminals to a new battery, it seemed to work (or at least power up) could it be a battery fault.I didn't think it was high drain equipment but the battery certainly looked like it had been short circuited or been subjected to a very high current drain." the reporter considered the event no incident.Follow up information has been received on (b)(6) 2019.Quality investigation has been completed.After several emails, still no response if the sample will be send for investigation.This record proceed without complaint sample.Executive summary as below: complaint description: from msd united kingdom we received a complaint concerning a tof watch.Tof machine had been used on a patient and left attached, but on top of the blankets when staff noticed a burning smell and then smoke coming from the machine, machine was burning hot and couldn't be held, (part of) battery inside had "melted".This concerns the first complaint for this tof watch (b)(4).The complaint was sent for investigation to the biometer.Conclusion: investigation results :no complaint sample will be supplied, meaning that a "desk investigation" only can be conducted at biometer.Speculative potential problem(s): the forwarded description indicate that the problem relates to a very high current drain (power consumption) within the device.The high-power consumption causes generation of heat within the battery which in turn causes "burning smell "and softening (melting) of plastic within the device battery compartment above potential speculative potential problem(s) cannot be confirmed without a physical investigation of the device.Identified possible root cause(s): no "true" (correct) root-cause can be identified/ concluded as the complaint sample device is not available for investigation at biometer.Speculative potential root cause(s) for the speculative problem: avery low resistance/ short-circuit /defect within the inserted 9v battery.Low resistance/ shortcircuit /defect within the battery may then have caused generation of heat, melted plastic and created burning smell.A foreign object within the battery compartment may have resulted in very low resistance/ shortcircuit towards the battery contact terminals of the inserted 9v battery.Low resistance/ short-circuit towards battery terminals caused generation of heat within the battery, melted plastic and created burning smell.Mechanical /electrical defect in the vicinity of the battery contact terminals may have resulted in very low resistance/ short-circuit towards the inserted 9v battery.Low resistance/ short-circuit towards battery caused generation of heat within the battery, melted plastic and created burning smell an internal electrical or mechanical defect within the device could potentially also result in in a high power consumption; however; the device electrical circuit has "a fuse" ("protective element'') just following the battery contact terminals and the fuse will in such situation quickly limit possible power drain from the battery and hereby void any excessive current drain and heat generation.The internal protection fuse could potentially be defective and then in combination with another electrical/ mechanical defect result in a high current drain.Such double-fault scenario is not considered that likely but cannot be excluded other unknown mechanical /electrical defect in this 10 year old device.It is noted that this is the first time/case where the above problem/defect description has been seen/ reported over the past 22 years where approx.50.000 tof-watch devices has been marketed.It observed that the device is 10 years old and some kind of "mechanical/electrical defect'' within the device battery compartment as a result of wear/use over many years is not unlikely.Impact on other product(s) / batches: no impact expected based upon the speculative root cause, however; reliable estimation of potential impact(s) is dependent on a "true" root-cause determination.Corrective and preventive actions: no biometer corrective actions will be initiated will be initiated as a result of this complaint as: the complaint description cannot be confirmed/ verified as no complaint sample is available.Determination of "correct/true" root cause only possible if a physical investigation of the complaint sample including patient cable can be made.Preventive actions: no biometer preventive actions will be initiated as: the complaint description cannot be confirmed and verified as no sample has been supplied.Complaint report data is entered into the biometer complaint/deviation statistics.These data are reviewed at least yearly for detection of possible trends, needs for improvement etcetera.If a high number of identical complaints/deviations is detected, actions may be started.An investigation into the manufacture of lot 01-2009190 was completed and confirmed that all in-process quality checks were satisfactory.The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures.The lot was confirmed to have met the requirements for market release.Following medical review of the ae report and the quality investigation, there were no identified concerns related to quality within the results of the investigation.Follow up information has been received on 16-oct-2019.On 31-oct-2019, our company received the compliant sample.Based on this investigation of the pqc, no systemic manufacturing inadequacy was identified at biometer manufacturing facility that could impact the quality attributes of the product.This record proceed with complaint sample.Complaint description: information received from medical device safety officer (mdso) of a university hospital via health authority, regarding a medical device issue, received on 11-sep-2019.Neuromuscular transmission monitor (tof watch) machine had been used on a patient and was left attached, but on top of blankets when staff noticed a burning smell and then smoke coming from the machine, machine was burning hot and couldn't be held, (part of) battery inside had 'melted'.The neuromuscular transmission monitor (tof watch) was removed from service and sent to clinical tech with battery included: serial number: (b)(4), quantity: 1, current location: critical care workshop quarantine, is the device certification (ce) marked: yes, date of incident: 08-jun-2018, and medicines and healthcare products regulatory agency (mhra) reference #: (b)(4).Follow-up 1 information received via email from the medical device safety officer at the hospital at 16 :13 on 25-oct-2019.Email stated " please see attached photographs as requested.The tof machine was packaged in the pre-paid envelope provided and placed in our outgoing mail system today, so should hopefully reach you in a few days." attached to the email was nine photographs.Related to ae record pr 260065.05-nov-2019 -second person reviewed s graves.05-nov-2019 ccc-pqc amended to stopped functioning and changed to high risk.11-nov-2019 ccc-debride code amended to fit stopped functioning.Complaint description summary: battery "melted'.Executive summary as below: msd united kingdom received a complaint concerning a tof watch.Tof machine had been used on a patient and left attached, but on top of the blankets when staff noticed a burning smell and then smoke coming from the machine, machine was burning hot and couldn't be held, (part of) battery inside had "melted".This concerns the first complaint for this tof watch 01-2009190.Complaint was investigated as full, items investigated according to wi 8.30.3i.The battery compartment of the device was seen clearly to be deformed as the result of a high (battery) temperature at some point in time.A defective component was present within the device.The component ic6 was not working due to an internal failure within the component.Speculative root- cause(s): it is considered unlikely that the identified def ective component (ic6) can have been the underlying cause for the excessive current drain from the battery which in turn had resulted in the high temperature.No excessive current drain was found during biometer investigations and no signs of high temperature or bum- marks (as normally would be present) could be identified on the pcb around ic6 or at any other place on the pcb.Beside from the lacking transducer voltage supply, the pcb/ device functioned as intended.Complaint sample: the battery compartment was seen clearly to be deformed as the result of a high (battery) temperature at some point in time.The enclosed patient cable, including a biometer supplied acceleration sensor, was connected to the device and a battery was inserted into the device battery compartment.The device was switched on and started up normally including correct display functionality.No high battery drains (current consumption) was seen.Following biometer investigations of the complaint sample, including patient cable, the most likely speculative root- cause(s) for the problem is consider ed to be: a foreign object within the battery compartment may have resulted in a very low resistance/ short-circuit towards the battery contact terminals of the inserted 9v battery.Low resistance/ short-circuit towards battery terminals caused generation of heat within the battery which in turn caused the plastic to soften/ deform and created the burning smell.Or a very low resistance / short-circuit / defect within the inserted 9v battery.Low resistance/ short-circuit/defect within the battery may then have caused generation of heat, softened plastic and created the burning smell.It is noted that no battery was enclosed with the complaint sample and no foreign objects was found during biometer investigations, however; this does not exclude the above speculative root- causes.No direct corrective actions will take place due to this complaint as: no direct root-cause or 100% firm conclusion can be made.The speculated potential root- causes are outside possible control.Th was the first time/case where the above problem/ defect has been seen/reported over the past 22 years where approx.50.000 tof-watch devices had been marketed.Preventive actions: no direct preventive actions will be taken as a result of this complaint.Complaint report data are entered into the biometer complaint statistics.These data are reviewed at least yearly for detection of possible trends, needs for improvement etcetera.If a high number of identical complaints will be detected, further actions would be started.
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Manufacturer Narrative
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Adverse event quality investigation has been completed.
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Event Description
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Tof machine had been used on a patient and was left attached, but on top the blankets when staff noticed a burning smell and then smoke coming from the machine, machine was burning hot and couldn't be held (part of) battery inside had "melted" [device battery issue] no adverse event to patient [no adverse event].Case narrative: info has been received from agency (b)(4) on 11-sep-2019.This initial spontaneous report originating from united kingdom has been received from a university hospital referring to an unknown patient of unknown age & gender.This report concerned 1 patient & 1 dv.Info regarding patient's medical history, drug reactions or allergies, concurrent conditions & concomitant medications not (b)(6)2019.This (b)(6) 2018, patient used a tof watch for an unknown indication.Tof watch left attached on top of blankets, n, staff noted a burning smell & a smoke that coming from tof watch which burning hot & couldn't be held; part of battery "melted" (dv battery issue).Tof watch available for investigation.For tof watch, lot number not available & serial number reported as (b)(4).For tof watch, quality investigation status: this case assessed as dv reportable & an adverse event quality investigation has been initiated.Fup info has been received from reporter on 18-sep-2019.It unknown where battery inserted correctly.Operator of tof watch a healthcare professional.Tof watch & battery were quarantined pending investigation.No adverse effect to patient & no ill effect.Reporter considered event not attributable to drug but attributable to dv because dv/ battery overheated.Medical dv safety officer discussed with clinical engineer & received following response: "i picked this up this morning & my initial thought that battery might have been put in upside down & terminals shorted on metal spring that usually supports base of 9 volt (v) cell.I had since spoken to senior sister & she informed me that event happened during use, & as far as she aware not after a battery change, so i disregarding above.I could see that battery swollen /misshapen & it had distorted plastic dv housing.It not possible to fit a new battery, but touching terminals to a new battery, it seemed to work (or at least power up) could it be a battery fault.I didn't think it high drain equipment but battery certainly looked like it had been short circuited or been subjected to a very high current drain." reporter considered event no incident.Fup info has been received on 17-oct-2019.Quality investigation has been completed.After several emails, still no response if sample will be send for investigation.This record proceed without complaint sample.Executive summary as below:complaint description: from msd united kingdom we received a complaint concerning a tof watch.Tof machine had been used on a patient & left attached, but on top of blankets when staff noticed a burning smell & n smoke coming from machine, machine burning hot & couldn't be held, (part of) battery inside had "melted".This concerns first complaint for this tof watch (b)(4).Complaint sent for investigation to biometer.Conclusion: investigation results: no complaint sample will be supplied, meaning that a "desk investigation" only can be conducted at biometer.Speculative potential problem(s): forwarded description indicate that problem relates to a very high current drain (power consumption) within dv.High-power consumption causes generation of heat within battery which in turn causes "burning smell "& softening (melting) of plastic within dv battery compartment above potential speculative potential problem(s) cannot be confirmed without a physical investigation of dv.Identified possible root cause(s): no "true" (correct) root-cause can be identified/ concluded as complaint sample dv is not available for investigation at biometer.Speculative potential root cause(s) for speculative problem: a very low resistance/ short-circuit /defect within inserted 9v battery.Low resistance/ shortcircuit /defect within battery may n have caused generation of heat, melted plastic & created burning smell.A foreign object within battery compartment may have resulted in very low resistance/ shortcircuit towards battery contact terminals of inserted 9v battery.Low resistance/ short-circuit towards battery terminals caused generation of heat within battery, melted plastic & created burning smell.Mechanical /electrical defect in vicinity of battery contact terminals may have resulted in very low resistance/ short-circuit towards inserted 9v battery.Low resistance/ short-circuit towards battery caused generation of heat within battery, melted plastic & created burning smell an internal electrical or mechanical defect within dv could potentially also result in a high power consumption; however; dv electrical circuit has "a fuse" ("protective element'') just following battery contact terminals & fuse will in such situation quickly limit possible power drain from battery & hereby void any excessive current drain & heat generation.Internal protection fuse could potentially be defective & n in combination with anor electrical/ mechanical defect result in a high current drain.Such double-fault scenario is not considered that likely but cannot be excluded or unknown mechanical /electrical defect in this 10 year old dv.It is noted that this is first time/case where above problem/defect description has been seen/ reported over past 22 years where approx.50.000 tof-watch dvs has been marketed.It observed that dv is 10 years old & some kind of "mechanical/electrical defect'' within dv battery compartment as a result of wear/use over many years is not unlikely.Impact on or product(s) / batches: no impact expected based upon speculative root cause, however; reliable estimation of potential impact(s) is dependent on a "true" root-cause determination.Corrective & preventive actions: no biometer corrective actions will be initiated will be initiated as a result of this complaint as: complaint description cannot be confirmed/ verified as no complaint sample is available.Determination of "correct/true" root cause only possible if a physical investigation of complaint sample including patient cable can be made.Preventive actions: no biometer preventive actions will be initiated as: complaint description cannot be confirmed & verified as no sample has been supplied.Complaint report data is entered into biometer complaint/deviation statistics.Se data are reviewed at least yearly for detection of possible trends, needs for improvement etc.If a high number of identical complaints/deviations is detected, actions may be started.An investigation into manufacture of lot 01-2009190 completed & confirmed that all in-process quality checks were satisfactory.Results indicated that lot manufactured in accordance with manufacturing site (b)(4) operating procedures.Lot confirmed to have met requirements for market release.Following medical review of ae report & quality investigation, re were no identified concerns related to quality within results of investigation.Fup info has been received on 16-oct-2019.On 31-oct-2019, our company received compliant sample.Based on this investigation of pqc, no systemic manufacturing inadequacy identified at biometer manufacturing facility that could impact quality attributes of product.This record proceed with complaint sample.Complaint description: info received from medical dv safety officer (mdso) of a (b)(6) hospital viahealth authority, regarding a medical dv issue, received on 11-sep-2019.Neuromuscular transmission monitor (tof watch) machine had been used on a patient & left attached, but on top of blankets when staff noticed a burning smell & n smoke coming from machine, machine burning hot & couldn't be held, (part of) battery inside had 'melted'.Neuromuscular transmission monitor (tof watch) removed from service & sent to clinical tech with battery included: serial number: (b)(4).Quantity: 1.Current location: (b)(4).Is dv certification (ce) marked: yes.Date of incident: (b)(6) 2018.Medicines & healthcare products regulatory agency (mhra) reference #: (b)(4).Fup1 info received via email from medical dv safety officer at hospital at 16 :13 on 25-oct-19.Email stated " tof machine packaged in pre-paid envelope provided & placed in our outgoing mail system today, so should hopefully reach you in a few days." related to ae record (b)(4).05-n-2019 -2nd person reviewed (b)(6) on 05-n-2019 ccc-pqc amended to stopped functioning & changed to high risk.(b)(4) code amended to fit stopped functioning 05-f-2020, complaint category has been changed from stopped functioning, n/a to stopped functioning, overheating indirect patient contact to reflect reporters issue accurately.05-f-2020, 2nd person review performed by (b)(6).Complaint description summary: battery "melted'.05-f-2020: complaint category updated to stopped functioning, overheating indirect patient contact executive summary as below: msd united kingdom received a complaint concerning a tof watch.Tof machine had been used on a patient & left attached, but on top of blankets when staff noticed a burning smell & n smoke coming from machine, machine burning hot & couldn't be held, (part of) battery inside had "melted".This concerns first complaint for this tof watch (b)(4).Complaint investigated as full, items investigated according to wi 8.30.3i.Battery compartment of dv seen clearly to be deformed as result of a high (battery) temperature at some point in time.A defective component present within dv.Component ic6 not working due to an internal failure within component.Preventive actions:no direct preventive actions will be taken as a result of this complaint.Complaint report data are entered into biometer complaint statistics.Se data are reviewed at least yearly for detection of possible trends, needs for improvement etc.If a high number of identical complaints will be detected, furr actions would be started.Based on this investigation of pqc, no systemic manufacturing inadequacy identified at biometer manufacturing facility that could impact quality attributes of product.Fup info has been received on 14-f-2020.A final lead investigation report has been completed.Executive summary:from msd uk we received a complaint about a stopped functioning tof watch, lot number 01-2009190.Tof machine had been used on a patient & left attached, but on top of blankets when staff noticed a burning smell & n smoke coming from machine, machine burning hot & couldn't be held, (part of) battery inside had "melted".Complaint investigated as full, items investigated according to (b)(4) battery compartment of dv seen clearly to be deformed as result of a high (battery) temperature at some point in time.A defective component present within dv.Component ic6 not working due to an internal failure within component.Speculative root-cause(s): it is considered unlikely that identified defective component (ic6) can have been underlying cause for excessive current drain from battery which in turn has resulted in high temperature.No excessive current drain found during biometer investigations & no signs of high temperature or burn-marks (as normally would be present) could be identified on pcb around ic6 or at any or place on pcb.Beside from lacking transducer voltage supply, pcb/dv functioned as intended.Complaint sample battery compartment seen clearly to be deformed as result of a high (battery) temperature at some point in time.Enclosed patient cable, including a biometer supplied acceleration sensor, connected to dv & a battery inserted into dv battery compartment.Dv switched on & started up normally including correct display functionality.No high battery drain (current consumption) seen.Following biometer investigations of complaint sample, including patient cable, most likely speculative root-cause(s) for problem is considered to be: a foreign object within battery compartment may have resulted in a very low resistance / short-circuit towards battery contact terminals of inserted 9v battery.Low resistance/ short-circuit towards battery terminals caused generation of heat within battery which in turn caused plastic to soften/deform & created burning smell.Or a very low resistance/ short-circuit /defect within inserted 9v battery.Low resistance/ short-circuit /defect within battery may n have caused generation of heat, softened plastic & created burning smell.It is noted that no battery enclosed with complaint sample & no foreign objects found during biometer investigations, however; this does not exclude above speculative root-causes.No direct corrective actions will take place due to this complaint as: no direct root-cause or 100% firm conclusion can be made.Speculated potential root-causes are outside possible control.This is first time/case where above problem/defect has been seen/ reported over past 22 years where approx.50.000 tof-watch dvs has been marketed.Preventive actions: no direct preventive actions will be taken as a result of this complaint.Complaint report data are entered into biometer complaint statistics.Se data are reviewed at least yearly for detection of possible trends, needs for improvement etc.If a high number of identical complaints will be detected, furr actions will be started.Based on this investigation of pqc, no systemic manufacturing inadequacy identified at biometer manufacturing facility that could impact quality attributes of product.Complaint sample description complaint sample is available for investigation & send to biometer.Investigation details:use of product tof watch is used for measurement of muscle relaxation using trainof four (tof) technique.Complaint: from msd uk we received a complaint about a stopped functioning tof watch, serial number (b)(4).Tof machine had been used on a patient & left attached, but on top of blankets when staff burning smell & n smoke coming from machine, machine burning hot & couldn't be held, battery inside had "melted".Reported patient outcome na no patient outcome reported.Associated capa remarks:no direct corrective actions will take place due to this complaint as:no direct root-cause or 100% firm conclusion can be made.Speculated potential root-causes are outside possible control.This is first time/case where above problem/defect has been seen / reported over past 22 years where approx.50.000 tof-watch dvs has been marketed.Preventive actions: no direct preventive actions will be taken as a result of this complaint.Complaint report data are entered into biometer complaint statistics.Se data are reviewed at least yearly for detection of possible trends, needs for improvement etc.If a high number of identical complaints will be detected, furr actions will be started.Root cause analysis speculative root-cause(s): it is considered unlikely that identified defective component (ic6) can have been underlying cause for excessive current drain from battery which in turn has resulted in high temperature.No excessive current drain found during biometer investigations & no signs of high temperature or burn-marks (as normally would be present) could be identified on pcb around ic6 or at any or place on pcb.Beside from lacking transducer voltage supply, pcb/dv functioned as intended.Following biometer investigations of complaint sample, including patient cable, most likely speculative root-cause(s) for problem is considered to be: a foreign object within battery compartment may have resulted in a very low resistance/ short-circuit towards battery contact terminals of inserted 9v battery.Low resistance/ short-circuit towards battery terminals caused generation of heat within battery which in turn caused plastic to soften/deform & created burning smell.Ora very low resistance/ short-circuit /defect within inserted 9v battery.Low resistance/ short-circuit /defect within battery may n have caused generation of heat, softened plastic & created burning smell.It is noted that no battery enclosed with complaint sample & no foreign objects found during biometer investigations, however; this does not exclude above speculative root-causes.
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Manufacturer Narrative
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Adverse event quality investigation has been completed.
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Event Description
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On top the blankets when staff noticed a burning smell and then smoke coming from the machine, machine was burning hot and couldn't be held (part of) battery inside had melted stopped functioning;overheating indirect patient contact no adverse event [device battery issue].No adverse event to patient [no adverse event].Case narrative: info has been received from agency ((b)(4)) on 11-sep-1209.This initial spontaneous report originating from uk has been received from a university hosp referring to an unknown pt of unknown age & gender.This report concerned 1 pt & 1 dv.Info regarding pt's mh, drug allergies, cc conditions & cc medications not provided.On(b)(6) 2018, pt used a tof watch for an unknown indication.Tof watch left attached on top of blankets & staff noted a burning smell & a smoke that coming from tof watch which burning hot & couldn't be held; part of battery(batt) "melted" (dv batt issue).Tof watch was available for inves.For tof watch, lot number & serial number reported as (b)(6).For tof watch, quality inves status: this case was assessed as dv reportable & an ae quality investigation(qi) has been initiated.Fu info has been received from reporter on 18-sep-2019.It was unknown whether batt inserted correctly.Operator of tof watch was a hcp.Tof watch & batt were quarantined pending inves.No ae & no ill effect were reported.The reporter considered the event not attributable to drug but attributable to dv because dv batt overheated.Mdso discussed with clinical engineer & received following response: "i picked this up this morning & my initial thought that batt might have been put in upside down & terminals shorted on metal spring that usually supports base of 9v cell.I had since spoken to senior sister & she informed me that the event happened during use, & as far as she was aware not after a batt change, so i disregarding above.I could see that batt swollen/misshapen & it had distorted plastic dv housing.It was not possible to fit a newbatt, but touching terminals to a new batt, it seemed to work (or at least power up).Could it be a batt fault? i didn't think it high drain eqpt but batt certainly looked like it had been short circuited or been subjected to a very high current drain." the reporter considered the event was no incident.Fu info has been received on 17-oct-1209.Qi has been completed.After several emails, still no response if sample would be send for inves.This record proceed without complaint sample.Executive summary(es) as below: complaint description(cd): from msd uk we received a complaint concerning a tof watch.Tof watch machine had been used on a pt & left attached, but on top of blankets when staff noticed a burning smell & smoke coming from machine, machine burning hot & couldn't be held, (part of) batt inside had "melted".This concerns first complaint for this tof watch 01-2009190.Complaint sent for inves to biometer.Conclusion: inves results: no complaint sample will be supplied, meaning that a "desk inves" only can be conducted at biometer.Speculative potential problem(s): forwarded description indicate that problem relates to a very high current drain (power consumption) within dv.High-power consumption causes generation of heat within batt which in turn causes "burning smell " & softening (melting) of plastic within dv batt compartment.Above potential speculative potential problem(s) couldn't be confirmed without a physical inves of dv.Identified possible root cause(s)(rc): no "true" (correct) root-cause could be identified/concluded as complaint sample dv was not available for inves at biometer.Speculative potential rc(s) for speculative problem: a very low r/s/defect within inserted 9v batt.Low resistance/shortcircuit(r/s)/defect within batt may n have caused generation of heat, melted plastic & created burning smell.A foreign object within batt compartment may have resulted in very low r/s towards batt contact terminals of inserted 9v batt.Low r/s towards batt terminals caused generation of heat within batt, melted plastic & created burning smell.Mechanical/electrical defect in vicinity of batt contact terminals may have resulted in very low r/s towards inserted 9v batt.Low r/s towards batt caused generation of heat within batt, melted plastic & created burning smell.An internal electrical or mechanical defect within dv could potentially also result in in a high power consumption; however, dv electrical circuit has "a fuse"("protective element'') just following batt contact terminals & fuse would in such situation quickly limit possible power drain from batt & hereby void, excessive current drain & heat generation.Internal protection fuse could potentially be defective & in combination with or electrical/mechanical defect result in a high current drain.Such double-fault scenario is not considered that likely but couldn't be excluded or unknown mechanical/electrical defect in this 10-year-old dv.It was noted that this is first time/case where above problem/defect description has been seen/reported over past 22 years where approx.50.000 tof watch dvs has been marketed.It observed that dv was 10 years old & some kind of "mechanical/electrical defect'' within dv batt compartment as a result of wear/use over many years was not unlikely.Impact on or product(s)/batches: no impact expected based upon speculative rc, however reliable estimation of potential impact(s) was dependent on a "true" root-cause determination.Corrective & preventive actions: no biometer corrective actions would be initiated will be initiated as a result of this complaint as: cd couldn't be confirmed/verified as no complaint sample is available.Determination of "correct/true" rc only possible if a physical inves of complaint sample including pt cable can be made.Preventive actions: no biometer preventive actions will be initiated as: cd cannot be confirmed & verified as no sample has been supplied.Complaint report data is entered into biometer complaint/deviation statistics.Se data are reviewed at least yearly for detection of possible trends, needs for improvement etc.If a high number of identical complaints/deviations is detected, actions may be started.An inves into manufacture of lot 01-2009190 completed & confirmed that all in-process quality checks were satisfactory.Results indicated that lot manufactured in accordance with mfr site standard operating procedures.Lot confirmed to have met requirements for market release.Following medical review of ae report & qi, re were no identified concerns related to quality within results of inves.Fup info has been received on 16-oct-2019.On 31-oct-2019, our company received compliant sample.Based on this inves of pqc, no systemic mfr inadequacy identified at biometer mfr facility that could impact quality attributes of product.This record proceed with complaint sample.Cd.Info received from mdso of a university hosp via health authority, regarding a medical dv issue, received on 11-sep-2019.Tof watch machine had been used on a pt & was left attached, but on top of blankets when staff noticed a burning smell & then smoke coming from machine, machine burning hot & couldn't be held, (part of) batt inside had 'melted'.Tof watch removed from service & sent to clinical tech with batt included: serial number: (b)(6) quantity:1;current location: critical care workshop quarantineis dv certification (ce) marked: yes.Date of incident: (b)(6) 2018.Medicines & healthcare products regulatory agency (mhra) reference #: (b)(4).Fu info received via email from medical dv safety officer at hosp at on 25-oct-2019.Email stated "please see attached photographs as requested.Tof watch machine packaged in pre-paid envelope provided & was placed in our outgoing mail system today, so should hopefully reach you in a few days."attached to email nine photographs.Related to ae record (b)(4).05-n-19-2nd person reviewed s graves 05-n-19 ccc-pqc amended to stopped functioning & changed to high risk.11-n-19 ccc-debride code amended to fit stopped functioning 05-f-20, complaint category has been changed from stopped functioning, n/a to stopped functioning, overheating indirect pt contact to reflect reporters issue accurately.05-f-20, 2nd person review performed by dhruti patel 06-f-20, j.King initial drr report attached cd summary: batt "melted'.05-f-20: complaint category updated to stopped functioning, overheating indirect pt contacts as below: msd uk received a complaint concerning a tof watch.Tof watch machine had been used on a pt & was left attached, but on top of blankets when staff noticed a burning smell & smoke coming from machine, machine burning hot & couldn't be held, (part of) batt inside had "melted".This concerns first complaint for this tof watch 01-2009190.Complaint investigated as full, items investigated according to wi 8.30.3i.Batt compartment of dv seen clearly to be deformed as result of a high (batt) temp at some point in time.A defective component present within dv.Component ic6 not working due to an internal failure within component.Preventive actions:no direct preventive actions will be taken as a result of this complaint.Complaint report data are entered into biometer complaint statistics.Se data are reviewed at least yearly for detection of possible trends, needs for improvement etc.If a high number of identical complaints will be detected, fractions would be started.Based on this inves of pqc, no systemic mfr inadequacy identified at biometer mfr facility that could impact quality attributes of product.Fup info has been received on 14-f-20.A final leadinves report has been completed.Es:from msd uk we received a complaint about a stopped functioning tof watch, lot number 01-2009190.Tof watch had been used on a pt & left attached, but on top of blankets when staff noticed a burning smell & smoke coming from machine, machine burning hot & couldn't be held, (part of) batt inside had "melted".Complaint investigated as full, items investigated according to wi 8.30.3i.Batt compartment of dv seen clearly to be deformed as result of a high (batt) temp at some point in time.A defective component present within dv.Component ic6 not working due to an internal failure within component.Speculative root-cause(s): it is considered unlikely that identified defective component (ic6) can have been underlying cause for excessive current drain from batt which in turn has resulted in high temp.No excessive current drain found during biometer invess & no signs of high temp or burn-marks (as normally would be present) could be identified on pcb around ic6 or at any or place on pcb.Beside from lacking transducer voltage supply, pcb/dv functioned as intended.Complaint sample batt compartment seen clearly to be deformed as result of a high (batt) temp at some point in time.Enclosed pt cable, including a biometer supplied acceleration sensor, connected to dv & a batt inserted into dv batt compartment.Dv switched on & started up normally including correct display functionality.No high batt drain(current consumption) seen.Following biometer invess of complaint sample, including pt cable, most likely speculative root-cause(s) for problem is considered to be: a foreign object within batt compartment may have resulted in a very low r/s towards batt contact terminals of inserted 9v batt.Low r/s towards batt terminals caused generation of heat within batt which in turn caused plastic to soften/deform & created burning smell.Or a very low r/s /defect within inserted 9v batt.Low r/s /defect within batt may n have caused generation of heat, softened plastic & created burning smell.It is noted that no batt enclosed with complaint sample & no foreign objects found during biometer invess, however; this does not exclude above speculative root-causes.No direct corrective actions will take place due to this complaint as: no direct root-cause or 100% firm conclusion can be made.Speculated potential root-causes are outside possible control.This was first time/case where above problem/defect has been seen/reported over past 22 years where approx.50.000 tof watch dvs has been marketed.Preventive actions: no direct preventive actions will be taken as a result of this complaint.Complaint report data are entered biometer complaint statistics.Data were reviewed at least yearly for detection of possible trends, needs for improvement etc.If a high number of identical complaints will be detected, furr actions will be started.Based on this inves of pqc, no systemic mfr inadequacy identified at biometer mfr facility that could impact quality attributes of product.Complaint sample description complaint sample is available for inves & send to biometer.Inves details:use of product tof watch was used for measurement of muscle relaxation using train of four (tof) technique.Complaint: from msd uk we received a complaint about a stopped functioning tof watch, serial number (b)(6).Tof watch machine had been used on a pt & left attached, but on top of blankets when staff burning smell & smoke coming from machine, machine burning hot & couldn't be held, batt inside had "melted".Reported pt outcome na no pt outcome reported.Associated capa remarks:no direct corrective actions will take place due to this complaint as:no direct root-cause or 100% firm conclusion can be made.Speculated potential root-causes are outside possible control.This is first time/case where above problem/defect has been see/reported over past 22 years where approx.(b)(4).Preventive actions: no direct preventive actions will be taken as a result of this complaint.Complaint report data are entered into biometer complaint statistics.Se data are reviewed at least yearly for detection of possible trends, needs for improvement etc.If a high number of identical complaints will be detected, furr actions will be started.Rc analysis speculative root-cause(s): it is considered unlikely that identified defective component (ic6) can have been underlying cause for excessive current drain from batt which in turn has resulted in high temp.No excessive current drain found during biometer invess & no signs of high temp or burn-marks (as normally would be present) could be identified on pcb around ic6 or at any or place on pcb.Beside from lacking transducer voltage supply, pcb/dv functioned as intended.Following biometer invess of complaint sample, including pt cable, most likely speculative root-cause(s) for problem is considered to be: a foreign object within batt compartment may have resulted in a very low resistance/ short-circuit towards batt contact terminals of inserted 9v batt low r/s towards batt terminals caused generation of heat within batt which in turn caused plastic to soften/deform & created burning smell.Or a very low r/s /defect within inserted 9v batt.Low r/s/defect within batt may n have caused generation of heat, softened plastic & created burning smell.It is noted that no batt enclosed with complaint sample & no foreign objects found during biometer invess, however; this does not exclude above speculative root-causes.Follow up information received on 26-feb-2020.Complaint description summary: 07-feb-2020, (b)(6) , corrected initial drr report attached.Es: from msd uk we received a complaint about a stopped functioning tof watch, lot number 01-2009190.Tof machine had been used on a pt & left attached, but on top of the blankets when staff noticed a burning smell & then smoke coming from the machine, machine was burning hot & couldn't be held, (part of) batt inside had "melted".Complaint was investigated as full, items investigated according to wi 8.30.3l.The batt compartment of the dv was seen clearly to be deformed as the result of a high (batt) temp at some point in time.A defective component was present within the dv.The component ic6 was not working due to an internal failure within the component.Speculative root-cause (s): it is considered unlikely that the identified defective component (ic6) can have been the underlying cause for the excessive current drain from the batt which in turn has resulted in the high temp.No excessive current drain was found during biometer invess & no signs of high temp or burn-marks (as normally would be present) could be identified on the pcb around ic6 or at any other place on the pcb.Beside from the lacking transducer voltage supply, the pcb/dv functioned as intended.Complaint sample: the batt compartment was seen clearly to be deformed as the result of a high (batt) temp at some point in time.The enclosed pt cable, including a biometer supplied acceleration sensor, was connected to the dv & a batt was inserted into the dv batt compartment.The dv was switched on & started up normally including correct display functionality.No high batt drain (current consumption) was seen.Following biometer invess of the complaint sample including pt cable, the most likely speculative root - cause (s) for the problem is considered to be: a foreign object within the batt compartment may have resulted in a very low resistance/ short- circuit towards the batt contact terminals of the inserted 9v batt.Low resistance/short circuit towards batt terminals caused generation of heat within the batt which in turn caused the plastic to soften/deform & created the burning smell.Or a very low resistance/short-circuit/defect within the inserted 9v batt.Low r/s/defect within the batt may then have caused generation of heat, softened plastic & created the burning smell.It is noted that no batt was enclosed with the complaint sample & no foreign objects was found during biometer invess, however; this does not exclude the above speculative root-causes.No direct corrective actions will take place due to this complaint as: no direct root-cause or 100% firm conclusion can be made.The speculated potential root causes are outside possible control.This is the first time/case where the above problem/ defect has been seen/reported over the past 22 years where approx.50.000 tof- watch dvs has been marketed.Preventive actions: no direct preventive actions will be taken as a result of this complaint.Complaint report data are entered the biometer complaint statistics.These data are reviewed at least yearly for detection of possible trends, needs for improvement etcetera.If a high number of identical complaints will be detected, further actions will be started.Based on this inves of the pqc, no systemic mfr inadequacy was identified at biometer mfr facility that could impact the quality attributes of the product.
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Search Alerts/Recalls
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