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

Model Number	MU-651RA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the biomed was informed by a monitor technician that someone at the facility may know the password and may have changed settings that resulted in alarms being turned off.This was discovered when ilyana, monitor technician noticed a waveform that should have generated an alarm but did not.Upon reviewing the bedside monitor settings, they found that the configuration did not match the settings of the other bedside monitors in the department.The end-user can adjust limits as needed to optimize monitoring of each patient, as well as limit alarm fatigue.The lowest that the spo2 lower limit can be adjusted is 50.If there was a reading of 18% that was witnessed, this would have been the patient's spo2 reading, not a lower limit setting.This desat would have triggered an alarm, which could have been silenced at the bedside or cns.Another possibility is that the spo2 lower limit could have been selected as "off." in this case, the lower limit setting would be irrelevant, and the monitor would not alarm for a desat.The logs are being collect to see what happened.No patient harm was reported.
Additional Manufacturer Narrative
The customer reported that the biomed was informed by a monitor technician that someone at the facility may know the password and may have changed settings that resulted in alarms being turned off.This was discovered when ilyana, monitor technician noticed a waveform that should have generated an alarm but did not.Upon reviewing the bedside monitor settings, they found that the configuration did not match the settings of the other bedside monitors in the department.The end-user can adjust limits as needed to optimize monitoring of each patient, as well as limit alarm fatigue.The lowest that the spo2 lower limit can be adjusted is 50.If there was a reading of 18% that was witnessed, this would have been the patient's spo2 reading, not a lower limit setting.This desat would have triggered an alarm, which could have been silenced at the bedside or cns.Another possibility is that the spo2 lower limit could have been selected as "off." in this case, the lower limit setting would be irrelevant, and the monitor would not alarm for a desat.The logs are being collect to see what happened.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.

• 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: 25682242
• Report Number: 8030229-2026-06754
• Device Sequence Number: 15883460
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: (01)04931921103548
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/01/2026

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2017
• 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: NI.
• Patient Sex: Unknown