MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6501A; VITAL SIGNS MONITOR

Model Number BSM-6501A

Device Problems No Audible Alarm (1019); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that their bedside monitor (bsm) did not have an audible alarm but had a visual alarm.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that their bedside monitor (bsm) did not have an audible alarm but had a visual alarm.The alarm could be seen and heard at the central nurses station (cns) and remote network station (rns).Technical support (ts) instructed them to turn the volume up and down to see if they heard any tones and reboot the bsm, but the issue persisted.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 Description

The biomedical engineer (bme) reported that their bedside monitor (bsm) did not have an audible alarm but had a visual alarm.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that their bedside monitor (bsm) did not have an audible alarm but had a visual alarm.The alarm could be seen and heard at the central nurses station (cns) and remote network station (rns).Technical support (ts) instructed them to turn the volume up and down to see if they heard any tones and reboot the bsm, but the issue persisted.No patient harm was reported.Investigation summary: we confirmed the issue was attributed to an issue with the monitor, as the speakers on the monitor were likely damaged, (possibly due to wear and tear damage and/or physical damage).In this case, the device was installed at the facility on (b)(6) 2008 and the warranty expired on 10/22/2013, indicating the device has aged approximately 15 (fifteen years), as such, the device is susceptible to wear and tear damage over time.The monitor was replaced to resolve the issue, and no further issues were reported.We have also identified several potential causes of audio sound issues, which are not limited to that speakers can become blown over time.Audio issues may still occur due to physical damage on the cable due to normal wear and tear or due to human factors.To mitigate such issues, any damaged hardware, monitors (with built in speakers) and other connected speakers, cables or hardware components can be replaced to mitigate damage issues.A review of historical data for the device did not reveal any trends that would contribute to component failure that is related to the design or manufacturing of the device.Moreover, this was found to be the only issue at the facility in the past 3 (three) years for this device and issue.In this case, the issue was resolved through ts and education provided to the customer.There is no evidence of an nk device malfunction that may have contributed to the reported issue.Trending will continue to be monitored.

• Brand Name: BSM-6501A
• Type of Device: VITAL SIGNS 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: 18397576
• MDR Text Key: 331380016
• Report Number: 8030229-2023-04006
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: 04931921103548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

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
• Device Operator: Health Professional
• Device Model Number: BSM-6501A
• Device Catalogue Number: MU-651RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CNS; CNS; RNS; RNS