MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3572A; VITAL SIGN MONITOR

Model Number	BSM-3572A
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The nihon kohden installer reported that the while installing this bedside monitor (bsm), it functions for about an hour while connected to the network and then either turns off or reboots.The bsm displays a blue screen with white lettering as well as sends out an alarm tone prior to the reboot.The displayed information has not been able to be captured due to the speed of the reboot or outage.Not in patient use.
Additional Manufacturer Narrative
The nihon kohden installer reported that the while installing this bedside monitor (bsm), it functions for about an hour while connected to the network and then either turns off or reboots.The bsm displays a blue screen with white lettering as well as sends out an alarm tone prior to the reboot.The displayed information has not been able to be captured due to the speed of the reboot or outage.Not in patient use.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
Event or Problem Description
The nihon kohden installer reported that while installing this bedside monitor (bsm), it functioned for only about an hour while connected to the network, then either turned off or rebooted.The bsm displayed a blue screen with white lettering and sent an alarm tone prior to the reboot.Not in patient use.
Additional Manufacturer Narrative
Details of complaint: the nihon kohden installer reported that while installing this bedside monitor (bsm), it functioned for only about an hour while connected to the network then either turned off or rebooted.The bsm displayed a blue screen with white lettering and sent an alarm tone prior to the reboot.No patient harm or injury was reported.Investigation summary: the customer was provided with an exchanged device and sent the reported device in for evaluation.During the evaluation, the customer's complaint was duplicated by nihon kohden repair center (nk rc).The issue was attributed to a software issue and the software was updated to resolve the issue.The device was then tested/inspected and met all specifications and was then dispositioned to nk stock inventory, as the customer was already provided with a replacement device.Nk was able to confirm the root cause of the reported issue was due to a software issue.The software was updated to resolve the issue.A review of the device complaint history does not reveal a significant trend that would suggest any design or manufacturing issues nor warrant any further corrective action.In this case, the nk rc team did not find any issues with the device and updated the software as a preventative measure.Trending will continue to be monitored for this device, incident issues and causes.

• Brand Name: BSM-3572A
• Common Device Name: VITAL SIGN MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14576734
• Report Number: 8030229-2022-02887
• Device Sequence Number: 5077523
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: 04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: BSM-3572A
• Device Catalogue Number: BSM-3572A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown