MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1773A; BEDSIDE MONITOR, NK SPO2

Model Number	BSM-1773A
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Device Operational Issue (2914); Compatibility Problem (2960)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pressure Sore/Ulcer (2326); Injury (2348); Patient Problem/Medical Problem (2688)
Date of Event	05/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The nursing manager reported that an spo2 probe caused a bruise on a neonate patient.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The nursing manager reported that an spo2 probe caused a bruise on a neonate patient.
Additional Manufacturer Narrative
Investigation result: this complaint is regarding spo2 probe causing injuries, not the malfunction of the monitoring device that the probe was connected to.The above incident was reported on (b)(6) 2018 during a go-live event.There are nine other incidents of injury from this go-live event.The issue is isolated to one customer: (b)(6) health system (account id (b)(6)).The following is the list of additional tickets related to this incident: (b)(4).In the nkc report (b)(4), it was reported that customer had placed the probe on the neonate patient for longer than the recommended maximum of 8 hours.The average attached time of the probe was 12 hours when the reported injury occurred.Customer had intended to keep the probe attached for 48 hours.Tl-052s is a disposable tape.The (b)(4) found that customer had reused the probe, which is not within the intended use of the probe.Operating manuals for g9 (csm-1000 series operator's manual, page 3-14) and bsm-1700 (operator's manual bsm-1700, page 123) posted warnings to change measurement sites for spo2 probes every 8 hours.Circulation condition should be checked by observing skin color at the measurement site and pulse waveforms.Extreme care should be taken when using probes on neonate or low birth weight infant with delicate skin.From an email by (b)(4), nk clinical applications specialist, on (b)(6) 2018, that during the go-live event, the customer stated the spo2 probes were lasting only three hours without them having to change the probe.This is alluding to the adhesive tape on the probe, although no clarification was provided.The situation became a huge expense to the unit and babies were having to stay longer based on desats that they felt may or may not be real due to the probe coming loose.Customer stated that the probe is stiff and hard which made to more difficult to get the sensors to touch the skin.The tape that came with these probes is very stretchy so they would put the probe on and if the tape was not tight enough the sensor would raise causing a false alarm.They would put the tape on tighter so that the sensor would not raise; this is when it would cause cuts to the babies' skin because the probe itself is hard.Based on the alleged spo2 inaccuracy and probe coming loose, the following queries were performed to see if these were recurring issues.A query for tickets related to "tl-052s" shows no other tickets than the ones listed above.A query for tickets related to "spo2 probe loose" shows no results.A query for tickets related to "spo2 accuracy" shows three incidents: (b)(4) - not relevant.Customer reported artifacts on waveforms rather than an alleged spo2 inaccuracy.(b)(4) - not relevant.Customer asked clinical knowledge question rather than an alleged spo2 inaccuracy.(b)(4) - investigation is in progress.Limited information available.Root cause has not been determined.Query results show tl-052s spo2 probe incidents were isolated to (b)(6) health system (account id (b)(6)).There are no known spo2 probes coming loose.There is one other incident of alleged spo2 inaccuracy that is still under investigation.Nkc's investigation results did not find issues with the hardness of the sensor area and tape shape for tl-052s.Risk analysis was performed under (b)(4).It was judged that the risk evaluation was acceptable.From the above information, it is concluded that the root cause was due to customer not being familiar with nk spo2 technology and have misused the product.The risks associated was determined by nk clinical department: if the spo2 probe is causing pressure marks on the neonate this could a serious concern as the neonate is not able to report the pain from the injury.The reddened pressure mark could cause tissue damage as well as inaccurate spo2 readings.Inaccurate spo2 reading could lead to over and/or under treating neonates with oxygen as well as delay in treatment.As a correction, customer had elected to have devices with nk spo2 technology swapped out for nellcor technology.This issue does not affect any other customers.Update: on 4/12/2019, customer sent an excel sheet containing information regarding eleven (11) cases.Ten (10) of which were mentioned above.Nk tech support is in contact with customer.Pending more information from customer.
Additional Manufacturer Narrative
Margie rogers from nk reported that an spo2 probe caused a bruise on a neonate patient.Aware date is 05/02/2018.Monitoring device: bsm-1773a sn not available.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: this is part of the collective incident reported from sparrow health system.Please see investigation performed under ticket (b)(4).Investigation from (b)(4): investigation result: this complaint is regarding spo2 probe causing injuries, not the malfunction of the monitoring device that the probe was connected to.The above incident was reported on (b)(6) 2018 during a go-live event.There are nine other incidents of injury from this go-live event.The issue is isolated to one customer: sparrow health system (account id (b)(4)).The following is the list of additional tickets related to this incident: (b)(4).In the nkc report a3-181213_final_eg, it was reported that customer had placed the probe on the neonate patient for longer than the recommended maximum of 8 hours.The average attached time of the probe was 12 hours when the reported injury occurred.Customer had intended to keep the probe attached for 48 hours.Tl-052s is a disposable tape.The a3-181213_final_eg found that customer had reused the probe, which is not within the intended use of the probe.Operating manuals for g9 (csm-1000 series operator's manual, page 3-14) and bsm-1700 (operator's manual bsm-1700, page 123) posted warnings to change measurement sites for spo2 probes every 8 hours.Circulation condition should be checked by observing skin color at the measurement site and pulse waveforms.Extreme care should be taken when using probes on neonate or low birth weight infant with delicate skin.From an email by (b)(6), nk clinical applications specialist, on 5/23/2018, that during the go-live event, the customer stated the spo2 probes were lasting only three hours without them having to change the probe.This is alluding to the adhesive tape on the probe, although no clarification was provided.The situation became a huge expense to the unit and babies were having to stay longer based on desats that they felt may or may not be real due to the probe coming loose.Customer stated that the probe is stiff and hard which made to more difficult to get the sensors to touch the skin.The tape that came with these probes is very stretchy so they would put the probe on and if the tape was not tight enough the sensor would raise causing a false alarm.They would put the tape on tighter so that the sensor would not raise; this is when it would cause cuts to the babies' skin because the probe itself is hard.Query results show tl-052s spo2 probe incidents were isolated to sparrow health system (account id 10104640).There are no known spo2 probes coming loose.There is one other incident of alleged spo2 inaccuracy that is still under investigation.Nkc's investigation results did not find issues with the hardness of the sensor area and tape shape for tl-052s.Risk analysis was performed under a701-0542323.It was judged that the risk evaluation was acceptable.From the above information, it is concluded that the root cause was due to customer not being familiar with nk spo2 technology and have misused the product.The risks associated was determined by nk clinical department: if the spo2 probe is causing pressure marks on the neonate this could a serious concern as the neonate is not able to report the pain from the injury.The reddened pressure mark could cause tissue damage as well as inaccurate spo2 readings.Inaccurate spo2 reading could lead to over and/or under treating neonates with oxygen as well as delay in treatment.As a correction, customer had elected to have devices with nk spo2 technology swapped out for nellcor technology.This issue does not affect any other customers.Corrected information: date of event: date incorrectly notated.Should be (b)(6) 2018 not (b)(6) 2018.Date uf/importer became aware of event: aware date on mdr initial should be 05/02/2018 not 05/03/2018.Approximate age of device: should be left blank, not 0 months as no serial # provided date received by manufacturer: should be 05/02/2018 not 05/30/2018 as listed on mdr initial report.Type of reportable event: serious injury should have been selected not malfunction on the mdr initial.Mdr follow up 002 has serious injury selected.Labeled for single use? should be marked as yes.No incorrectly selected on mdr initial.Corrected on mdr follow up 002.Additional information: outcomes attributed to adverse event, date of this report, concomitant medical products, initial reporter - occupation, date user facility/importer became aware of the event, type of report, date report sent to fda, date report sent to manufacturer, date received by manufacturer, type of report, if follow-up, what type?, additional information, correction, event problem and evaluation codes.The following fields are not applicable (n/a) to this report: suspect products, lot # & expiration date (na for the bsm not for the spo2 probe).The following fields contain no information (ni), as attempts to obtain information were made, but not provided: patient information: age at time of event, date of birth, sex, weight, ethnicity, race, relevant tests/laboratory data, including dates, other relevant history, including preexisting medical conditions, serial #, approximate age of device for bedside monitor, device manufacture date for bedside monitor.Concomitant medical products: spo2 probe information: model: tl-052s, lot: not provided, expiration date: not provided, unique identifier (udi) #: (b)(4), is this a single-use device that was reprocessed and reused on a patient? no probes used in this incident were not returned.The spo2 probe was used in conjunction with the bedside monitor.Approximate age of device for spo2 probe.Device manufacture date for spo2 probe.Labeled for single use? yes.Usage of device: reuse.The probe is labeled for single use but the customer re-used it anyway which resulted in a patient injury.
Event or Problem Description
The nursing manager reported that an spo2 probe caused a bruise on a neonate patient.

• Brand Name: BSM-1773A
• Common Device Name: BEDSIDE MONITOR, NK SPO2
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7555516
• Report Number: 8030229-2018-00188
• Device Sequence Number: 1317152
• Product Code: MHX
• UDI-Device Identifier: 04931921111956
• UDI-Public: 4931921111956
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2019
• Report Date (Section F): 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BSM-1773A
• Device Catalogue Number: BSM-1773A
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/29/2019
• Device Age: 0 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 05/30/2018; 04/29/2019
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 04/12/2019; 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPO2 PROBE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Date Report Sent to FDA: 09/06/2019