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

Model Number	BSM-3572A
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Output Problem (3005); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the displays on the bedside monitor are turning black.They stated that all their bsm-3500s from the site do this randomly.This has been happening since go live.Not all the units are having this issue at this time.They stated that this has been happening to all their unit at one time or another and happens randomly.No patient harm was 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 biomedical engineer (bme) reported that the displays on the bedside monitor are turning black.They stated that all their bsm-3500s from the site do this randomly.This has been happening since go live.Not all the units are having this issue at this time.They stated that this has been happening to all their unit at one time or another and happens randomly.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the display screens on all the bedside monitors (bsm-3500s) at this facility were randomly going black.This had been occurring since the go live.No patient harm or injury was reported.Investigation summary: nka technical support (ts) performed troubleshooting but was not able to identify an issue with the device configuration or the hospital's network configuration that may have contributed to the issue.The issue was believed to be at the device level.It was believed that the device had a fatal error on the system and needed its software to be reinstalled or upgraded.The customer was sent the updated software, and no further issues were reported.The root cause is likely related to a software deficiency and the use of outdated software.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal similar complaints.Attempt #1: 08/03/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded with complaint details, but did not provide the requested information.
Event or Problem Description
The biomedical engineer (bme) reported that the display screens on all the bedside monitors (b)(4) at this facility were randomly going black.This had been occurring since the go live.No patient harm was 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17561554
• Report Number: 8030229-2023-03709
• Device Sequence Number: 12497681
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: 04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/17/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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