MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION LIFE SCOPE TR; BEDSIDE MONITOR

Model Number	MU-651RA
Medical Device Problem Codes	Device Alarm System (1012); No Audible Alarm (1019); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) was not audibly sounding any alarms during setup, but the alarms were sounding at the central nurse's station (cns).Nk's cits had them reboot the bsm and ensured that all alarms were enabled.The bme used simulated data to create the alarms.Ts had him switch the bsm from the icu to the or, then back to the icu to try and reset the alarm settings.There were still no audible alarms coming from the bsm.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.The following field contains limited information, as an attempt to obtain the information was made, but not all of it was provided: d10.Attempt # 1: 11/19/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the bsm: bsm: model #: bsm-1753a.Serial #: (b)(6).Device manufacturer data: 02/13/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Cns: model #: cns-6801a.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) was not audibly sounding any alarms during setup, but the alarms were sounding at the central nurse's station (cns).No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) was not audibly sounding any alarms during setup, but the alarms were sounding at the central nurse's station (cns).No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) was not audibly sounding any alarms during setup, but the alarms were sounding at the central nurse's station (cns).Nk's cits had them reboot the bsm and ensured that all alarms were enabled.The bme used simulated data to create the alarms.Ts had him switch the bsm from the icu to the or, then back to the icu to try and reset the alarm settings.There were still no audible alarms coming from the bsm.No patient harm was reported.Investigation summary: the complaint device was returned to nk for evaluation and repair.During the evaluation, they found that the label logo, (mu-651ra) was missing and the operation panel was peeling off.During testing, the reported issue was duplicated, and the cause was determined to be software corruption and the failure of a hardware component within the operation panel.Nk will continue to monitor and trend.The following field contains limited information, as an attempt to obtain the information was made, but not all of the information was provided: additional device information: d10.Concomitant medical device: the following devices were used in conjunction with the model #: bsm-1753a.Serial #: (b)(6).Device manufacturer data: 02/13/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Cns: model #: cns-6801a.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.Additional information: b4.Date of this report.G3.Date received by manufacturer.G6.Type of report.H2.If follow-up, what type? h6.Event problem and evaluation codes.H11.Additional manufacturer narrative.

• Brand Name: LIFE SCOPE TR
• Common Device Name: BEDSIDE 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: 23785405
• Report Number: 8030229-2025-05935
• Device Sequence Number: 5128836
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: (01)04931921103548
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/02/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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: BSM (BSM-1753A).; BSM (BSM-1753A).; CNS (NO SN WAS PROVIDED).; CNS (NO SN WAS PROVIDED).
• Patient Sex: Unknown