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

Model Number	BSM-3572A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the staff reported that numerics on the bedside monitor (bsm) seem to jump up and down randomly, intermittently and not in tune with patient's condition.The staff reported it as glitching.The customer did not want to troubleshoot and asked that nk send someone to look at the issue as this is happening on two other monitors (tickets (b)(4)).The field engineer and the installer were both sent to the site and observed the monitors for a few hours, but did not see the issue.The engineer updated the software on this unit.There was no patient injury reported.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 customer reported that the staff reported that numerics on the bedside monitor (bsm) seem to jump up and down randomly, intermittently and not in tune with patient's condition.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the numerics on the bedside monitor (bsm) were jumping up and down randomly and were not in line with patient's condition.No patient harm or injury was reported.Investigation summary: the customer did not want to troubleshoot the issue and requested an on-site visit from nihon kohden (nk).A field engineer and the installer were sent to the site to investigate the issue further, who observed the monitors for a few hours.However, they were unable to duplicate, confirm, nor observe the reported issue.The engineer updated the software on the device, (bsm-3572a-q01, serial number (b)(6), and no further issues were reported.Nk was unable to confirm or determine the root cause of the reported issue.However, it is possible the issue could have been related to a software issue, as the software was updated as a preventative measure.There have been no issues reported since the software update.A review of the device and 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, our nk on-site 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 03/18/2022 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.Attempt # 2: 03/22/2022 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.Attempt # 3: 03/24/2022 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.
Event or Problem Description
The customer reported that the numerics on the bedside monitor (bsm) were jumping up and down randomly, and were not in line with patient's condition.There was no patient injury reported.

• 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: 14079346
• Report Number: 8030229-2021-02735
• Device Sequence Number: 5251568
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: 04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Biomedical Engineer
• 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: Health Professional
• Device Model Number: BSM-3572A
• Device Catalogue Number: BSM-3572A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 07/08/2023
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• 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