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| Lot Number 08-2010032 |
| Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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| Patient Problem
Suffocation (2088)
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Event Type
Injury
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Event Description
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Impossibility to breath/was not able to spontaneously ventilate [apnoea].Suffocation [asphyxia].Defect of reliability of curarisation monitoring was suspected/residual curarisation not detected [device malfunction].Case narrative: this initial spontaneous report originating from (b)(6) as received from (b)(6) (ref.# (b)(4)), via (b)(6), refers to a (b)(6)-year-old female patient.The original source of information was a physician.This report concerns 1 patient and 2 devices.On (b)(6) 2019, the patient was operated for "broncho-dilation".During this operation neuromuscular transmission monitor (tof watch sx) (reported as tof watch) lot# 57-2010039, expiration date not reported but upon internal validation established as 30-sep-2021, was used for curarization monitoring.The monitor announced decurarization at 90 percent and 4 responses after stimulation while no reaction was visualized for this stimulation.An another neuromuscular transmission monitor (tof watch sx) lot# 47-2010056, expiration date not reported but upon internal validation established as 01-oct-2021 or lot# 08-2010070, expiration date not reported but upon internal validation established as 01-dec-2021 was used.The second monitor indicated 4 response and decurarization at 93 percent.The patient's laryngeal mask was removed based on these results.The patient was not able to spontaneously ventilate due to residual curarization which was not detected by the two used monitors.The reporter stated that these devices were not reliable because delivered false information.The patient received injection of neostigmine and atropine as a matter of emergency.It was reported that the patient kept a very precise memory of suffocation and impossibility to breath.The outcome of the events of impossibility to breath and suffocation was considered as recovered.The reporter considered these events to be related to neuromuscular transmission monitor (tof watch sx).Upon internal review, the events of impossibility to breath and suffocation were determined to be medically significant.Both events required intervention as medical intervention (injection of neostigmine and atropine) was necessary to preclude permanent impairment of a body function.The neuromuscular transmission monitor (tof watch sx) was available for investigation.For neuromuscular transmission monitor (tof watch sx), the lot number was reported as 57-2010039 and the serial number is not available.For neuromuscular transmission monitor (tof watch sx), quality investigation status: reportable malfunction/ (potential) incident identified.Investigation in progress.During validation, it was determined that all lot numbers belonged to neuromuscular transmission monitor (tof watch sx) not neuromuscular transmission monitor (tof watch).This is one of three reports regarding the same patient (cross-referred with reports# (b)(4)).This is an amendment report.For technical reasons the case # (b)(4) is a duplicate of case (b)(4).Therefore, case # (b)(4) is being deleted from our files and the cases are consolidated into case # (b)(4).
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Manufacturer Narrative
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The device itself was investigated.
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Event Description
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Impossibility to breath/was not able to spontaneously ventilate [apnoea] suffocation [asphyxia].Defect of reliability of curarisation monitoring was suspected/residual curarisation not detected [device malfunction].Case narrative: this initial spontaneous report originating from france as received from french national agency for medicines and health products safety (ansma) (ref.# (b)(4)), via (b)(6), refers to a 60-year-old female patient.The original source of information was a physician.This report concerns 1 patient and 2 devices.On (b)(6) 2019, the patient was operated for "broncho-dilation".During this operation neuromuscular transmission monitor (tof watch sx) (reported as tof watch) lot# 57-2010039, expiration date not reported but upon internal validation established as 30-sep-2021, was used for curarization monitoring.The monitor announced decurarization at 90 percent and 4 responses after stimulation while no reaction was visualized for this stimulation.An another neuromuscular transmission monitor (tof watch sx) lot# 47-2010056, expiration date not reported but upon internal validation established as 01-oct-2021 or lot# 08-2010070, expiration date not reported but upon internal validation established as 01-dec-2021 was used.The second monitor indicated 4 response and decurarization at 93 percent.The patient's laryngeal mask was removed based on these results.The patient was not able to spontaneously ventilate due to residual curarization which was not detected by the two used monitors.The reporter stated that these devices were not reliable because delivered false information.The patient received injection of neostigmine and atropine as a matter of emergency.It was reported that the patient kept a very precise memory of suffocation and impossibility to breath.The outcome of the events of impossibility to breath and suffocation was considered as recovered.The reporter considered these events to be related to neuromuscular transmission monitor (tof watch sx).Upon internal review, the events of impossibility to breath and suffocation were determined to be medically significant.Both events required intervention as medical intervention (injection of neostigmine and atropine) was necessary to preclude permanent impairment of a body function.The neuromuscular transmission monitor (tof watch sx) was available for investigation.For neuromuscular transmission monitor (tof watch sx), the lot number was reported as 57-2010039 and the serial number is not available.For neuromuscular transmission monitor (tof watch sx), quality investigation status: reportable malfunction/ (potential) incident identified.Investigation in progress.During validation, it was determined that all lot numbers belonged to neuromuscular transmission monitor (tof watch sx) not neuromuscular transmission monitor (tof watch).This is one of three reports regarding the same patient (cross-referred with reports# (b)(4)).Follow-up information was received on 21-aug-2019.A quality investigation was performed and the result was that the lot number reported was incorrect, the correct lot number was 08-2010032; also, based on the conducted 3 separate investigations, related findings for the involved devices it did not seem likely that any combination of the devices could have given such annunciations/readings as described.It was also evident that the devices were exposed to conditions well beyond the recommended storage and use conditions as described in user manual, with multiple objective evidence of liquid ingress as well as severe mechanical impact.Those are beyond the conditions to which the system was designed to.As a result the performance and functional specifications of the neuromuscular transmission monitor (tof watch sx) cannot be ensured.Therefore, it was also reported that no corrective actions will be initiated given that the observed device/cable/transducer defected within this 9 year old device and cables relate to/originate from exposure to repeated very hard handling far outside what was intended (like liquid spillage into device and drops/hard impacts).Follow-up information was received on 03-sep-2019.An investigation into the manufacture of lot# 57-2010039 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.Lot number 08-2010032 has been verified to be a valid lot number for neuromuscular transmission monitor.
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Event Description
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Impossibility to breath/was not able to spontaneously ventilate [apnoea].Suffocation [asphyxia].Defect of reliability of curarisation monitoring was suspected/residual curarisation not detected [device malfunction].Case narrative: this initial spontaneous report originating from france as received from french national agency for medicines and health products safety (ansma) (ref.# (b)(4)), via alsevia pharma and mipm mammendorfer lnstitut, refers to a 60-year-old female patient.The original source of information was a physician.This report concerns 1 patient and 2 devices.On (b)(6) 2019, the patient was operated for "broncho-dilation".During this operation neuromuscular transmission monitor (tof watch sx) (reported as tof watch) lot# 57-2010039, expiration date not reported but upon internal validation established as 30-sep-2021, was used for curarization monitoring.The monitor announced decurarization at 90 percent and 4 responses after stimulation while no reaction was visualized for this stimulation.An another neuromuscular transmission monitor (tof watch sx) lot# 47-2010056, expiration date not reported but upon internal validation established as 01-oct-2021 or lot# 08-2010070, expiration date not reported but upon internal validation established as 01-dec-2021 was used.The second monitor indicated 4 response and decurarization at 93 percent.The patient's laryngeal mask was removed based on these results.The patient was not able to spontaneously ventilate due to residual curarization which was not detected by the two used monitors.The reporter stated that these devices were not reliable because delivered false information.The patient received injection of neostigmine and atropine as a matter of emergency.It was reported that the patient kept a very precise memory of suffocation and impossibility to breath.The outcome of the events of impossibility to breath and suffocation was considered as recovered.The reporter considered these events to be related to neuromuscular transmission monitor (tof watch sx).Upon internal review, the events of impossibility to breath and suffocation were determined to be medically significant.Both events required intervention as medical intervention (injection of neostigmine and atropine) was necessary to preclude permanent impairment of a body function.The neuromuscular transmission monitor (tof watch sx) was available for investigation.For neuromuscular transmission monitor (tof watch sx), the lot number was reported as 57-2010039 and the serial number is not available.For neuromuscular transmission monitor (tof watch sx), quality investigation status: reportable malfunction/ (potential) incident identified.Investigation in progress.During validation, it was determined that all lot numbers belonged to neuromuscular transmission monitor (tof watch sx) not neuromuscular transmission monitor (tof watch).This is one of three reports regarding the same patient (cross-referred with reports# (b)(4)).Follow up information was received on 21-aug-2019.A quality investigation was performed and the result was that the lot number reported was incorrect, the correct lot number was 08-2010032; also, based on the conducted 3 separate investigations, related findings for the involved devices it did not seem likely that any combination of the devices could have given such annunciations/readings as described.It was also evident that the devices were exposed to conditions well beyond the recommended storage and use conditions as described in user manual, with multiple objective evidence of liquid ingress as well as severe mechanical impact.Those are beyond the conditions to which the system was designed to.As a result the performance and functional specifications of the neuromuscular transmission monitor (tof watch sx) cannot be ensured.Therefore, it was also reported that no corrective actions will be initiated given that the observed device/cable/transducer defected within this 9 year old device and cables relate to/originate from exposure to repeated very hard handling far outside what was intended (like liquid spillage into device and drops/hard impacts).
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Manufacturer Narrative
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The device itself was investigated.
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Event Description
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Impossibility to breath/was not able to spontaneously ventilate [apnoea] suffocation [asphyxia] defect of reliability of curarisation monitoring was suspected/residual curarisation not detected [device malfunction] case narrative: this initial spontaneous report originating from france as received from french national agency for medicines and health products safety (ansma) (ref.# (b)(4)), via alsevia pharma and mipm mammendorfer lnstitut, refers to a 60-year-old female patient.The original source of information was a physician.This report concerns 1 patient and 2 devices.On (b)(6) 2019, the patient was operated for "broncho-dilation".During this operation neuromuscular transmission monitor (tof watch sx) (reported as tof watch) lot# 57-2010039, expiration date not reported but upon internal validation established as 30-sep-2021, was used for curarization monitoring.The monitor announced decurarization at 90 percent and 4 responses after stimulation while no reaction was visualized for this stimulation.An another neuromuscular transmission monitor (tof watch sx) lot# 47-2010056, expiration date not reported but upon internal validation established as 01-oct-2021 or lot# 08-2010070, expiration date not reported but upon internal validation established as 01-dec-2021 was used.The second monitor indicated 4 response and decurarization at 93 percent.The patient's laryngeal mask was removed based on these results.The patient was not able to spontaneously ventilate due to residual curarization which was not detected by the two used monitors.The reporter stated that these devices were not reliable because delivered false information.The patient received injection of neostigmine and atropine as a matter of emergency.It was reported that the patient kept a very precise memory of suffocation and impossibility to breath.The outcome of the events of impossibility to breath and suffocation was considered as recovered.The reporter considered these events to be related to neuromuscular transmission monitor (tof watch sx).Upon internal review, the events of impossibility to breath and suffocation were determined to be medically significant.Both events required intervention as medical intervention (injection of neostigmine and atropine) was necessary to preclude permanent impairment of a body function.The neuromuscular transmission monitor (tof watch sx) was available for investigation.For neuromuscular transmission monitor (tof watch sx), the lot number was reported as 57-2010039 and the serial number is not available.For neuromuscular transmission monitor (tof watch sx), quality investigation status: reportable malfunction/ (potential) incident identified.Investigation in progress.During validation, it was determined that all lot numbers belonged to neuromuscular transmission monitor (tof watch sx) not neuromuscular transmission monitor (tof watch).This is one of three reports regarding the same patient (cross-referred with reports# fr-009507513-1907fra013797 and fr-009507513-1907fra013859).Follow up information was received on 21-aug-2019.A quality investigation was performed and the result was that the lot number reported was incorrect, the correct lot number was 08-2010032; also, based on the conducted 3 separate investigations, related findings for the involved devices it did not seem likely that any combination of the devices could have given such annunciations/readings as described.It was also evident that the devices were exposed to conditions well beyond the recommended storage and use conditions as described in user manual, with multiple objective evidence of liquid ingress as well as severe mechanical impact.Those are beyond the conditions to which the system was designed to.As a result the performance and functional specifications of the neuromuscular transmission monitor (tof watch sx) cannot be ensured.Therefore, it was also reported that no corrective actions will be initiated given that the observed device/cable/transducer defected within this 9 year old device and cables relate to/originate from exposure to repeated very hard handling far outside what was intended (like liquid spillage into device and drops/hard impacts).Follow up information was received on 03-sep-2019.An investigation into the manufacture of lot# 57-2010039 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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Manufacturer Narrative
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The device itself was investigated.
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Manufacturer Narrative
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The device itself was investigated.
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Event Description
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Impossibility to breath/was not able to spontaneously ventilate [apnoea].Suffocation [asphyxia].Defect of reliability of curarisation monitoring was suspected/residual curarisation not detected [device malfunction].Case narrative: this initial spontaneous report originating from france as received from french national agency for medicines and health products safety (ansma) (ref.# (b)(4)), via alsevia pharma and mipm mammendorfer lnstitut, refers to a 60-year-old female patient.The original source of information was a physician.This report concerns 1 patient and 2 devices.On (b)(6) 2019, the patient was operated for "broncho-dilation".During this operation neuromuscular transmission monitor (tof watch sx) (reported as tof watch) lot# 57-2010039, expiration date not reported but upon internal validation established as 30-sep-2021, was used for curarization monitoring.The monitor announced decurarization at 90 percent and 4 responses after stimulation while no reaction was visualized for this stimulation.An another neuromuscular transmission monitor (tof watch sx) lot# 47-2010056, expiration date not reported but upon internal validation established as 01-oct-2021 or lot# 08-2010070, expiration date not reported but upon internal validation established as 01-dec-2021 was used.The second monitor indicated 4 response and decurarization at 93 percent.The patient's laryngeal mask was removed based on these results.The patient was not able to spontaneously ventilate due to residual curarization which was not detected by the two used monitors.The reporter stated that these devices were not reliable because delivered false information.The patient received injection of neostigmine and atropine as a matter of emergency.It was reported that the patient kept a very precise memory of suffocation and impossibility to breath.The outcome of the events of impossibility to breath and suffocation was considered as recovered.The reporter considered these events to be related to neuromuscular transmission monitor (tof watch sx).Upon internal review, the events of impossibility to breath and suffocation were determined to be medically significant.Both events required intervention as medical intervention (injection of neostigmine and atropine) was necessary to preclude permanent impairment of a body function.The neuromuscular transmission monitor (tof watch sx) was available for investigation.For neuromuscular transmission monitor (tof watch sx), the lot number was reported as 57-2010039 and the serial number is not available.For neuromuscular transmission monitor (tof watch sx), quality investigation status: reportable malfunction/ (potential) incident identified.Investigation in progress.During validation, it was determined that all lot numbers belonged to neuromuscular transmission monitor (tof watch sx) not neuromuscular transmission monitor (tof watch).This is one of three reports regarding the same patient (cross-referred with reports# (b)(4) and (b)(4)).Follow up information was received on 21-aug-2019.A quality investigation was performed and the result was that the lot number reported was incorrect, the correct lot number was 08-2010032; also, based on the conducted 3 separate investigations, related findings for the involved devices it did not seem likely that any combination of the devices could have given such annunciations/readings as described.It was also evident that the devices were exposed to conditions well beyond the recommended storage and use conditions as described in user manual, with multiple objective evidence of liquid ingress as well as severe mechanical impact.Those are beyond the conditions to which the system was designed to.As a result the performance and functional specifications of the neuromuscular transmission monitor (tof watch sx) cannot be ensured.Therefore, it was also reported that no corrective actions will be initiated given that the observed device/cable/transducer defected within this 9 year old device and cables relate to/originate from exposure to repeated very hard handling far outside what was intended (like liquid spillage into device and drops/hard impacts).Follow-up information was received on 03-sep-2019.An investigation into the manufacture of lot# 57-2010039 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.Lot number 08-2010032 has been verified to be a valid lot number for neuromuscular transmission monitor.Follow-up information was received from fda on 09-dec-2021.The device problem codes were updated.Local comments: e2b resubmission following e2b failure and subsequent fix by msd.
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Search Alerts/Recalls
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