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

Model Number BSM-6501A

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the speaker was no longer making a sound from the bedside monitor (bsm).The visual alarm indicator in the room is working fine but the audible alarms cannot be heard.The alarms for the bsm are alarming at the central nurse's station (cns) and remote network station (rns).The customer requested the part number be provided, for the speaker to be replaced onsite.Not in patient use.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the speaker was no longer making a sound from the bedside monitor (bsm).The visual alarm indicator in the room is working fine but the audible alarms cannot be heard.The alarms for the bsm are alarming at the central nurse's station (cns) and remote network station (rns).The customer requested the part number be provided, for the speaker to be replaced onsite.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.Investigation conclusion: we confirmed the issue was attributed to an issue with the speaker, 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 03/27/2010 and the warranty expired on 03/27/2015, indicating the device has aged approximately 14 (fourteen years).Due to aging and degradation over time, the device and its hardware and components, (speakers), are susceptible to wear and tear damage.The customer was provided with the part number and instructions on how to order replacement speakers, to resolve the issue.Despite qa investigator follow-up attempt to gather any additional information, there has been no reply from the customer.Moreover, no further issues related to this incident were reported.

• 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: 19140886
• MDR Text Key: 340689407
• Report Number: 8030229-2024-04214
• 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
• Report Date: 04/18/2024

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: Not provided
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2009
• 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