MAUDE Adverse Event Report: Nihon Kohden Corporation Life Scope TR; Bedside Monitor

Model Number	MU-631RA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported unusual arrhythmia alarms on the bedside monitor (bsm), which displayed hr/pr as a single parameter.Technical support (ts) found the sync source in the spo2 settings was set to ecg and changed it to spo2, initially resolving the alarms.The issue later returned, with pr displayed and doubled.No reports of patient harm.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported unusual arrhythmia alarms on the bedside monitor (bsm), which displayed hr/pr as a single parameter.Technical support (ts) found the sync source in the spo2 settings was set to ecg and changed it to spo2, initially resolving the alarms.The issue later returned, with pr displayed and doubled.The bsm was monitoring spo2 directly while zm-view was used for ecg only.Ts had the bme connect a test bsm in the same configuration, and the issue was reproduced after approximately two minutes, with pr appearing doubled.Clinical settings from a functioning bsm in zm-view were copied and loaded to the affected unit; however, there was no change.The issue also persisted after replacing the spo2 cable.The issue occurred only when the spo2 finger probe was connected.Without the probe, the bsm and central nurse station (cns) operated normally, and spo2 pr did not appear.Troubleshooting was then performed without zm telemetry unit.After removing the zm unit from the setup, the issue did not recur during the observation period.Monitor readings and side-panel settings remained normal, and the spo2 pr display no longer appeared.No reports of patient harm.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.

• 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: 50855706
• Report Number: 8030229-2026-07079
• Device Sequence Number: 9652038
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: (01)04931921103517
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 09/22/2026

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-631RA
• Device Catalogue Number: MU-631RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2017
• 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.; ORG.; ZM transmitter.
• Patient Sex: Unknown