MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION LIFE SCOPE TR; VITAL SIGNS MONITOR (BSM-6500 MAIN UNIT)

Model Number	MU-651RA
Medical Device Problem Codes	No Audible Alarm (1019); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Udi related data quality updates.Corrected information: d1 brand name: corrected the brand name from bsm-6501a to life scope tr.D4 additional device information / model #: corrected the model # from bsm-6501a to mu-651ra.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the pi information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.
Event or Problem 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.

• Brand Name: LIFE SCOPE TR
• Common Device Name: VITAL SIGNS MONITOR (BSM-6500 MAIN UNIT)
• 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
• Report Number: 8030229-2023-04006
• Device Sequence Number: 16819115
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: (01)04931921103548(21)5
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 08/06/2024

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: MU-651RA
• Device Catalogue Number: MU-651RA
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 02/29/2024; 02/29/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 03/04/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2008
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CNS; CNS; CNS; RNS; RNS; RNS
• Patient Sex: Unknown