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

Model Number	MU-631RA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor discharged a patient on its own and went straight into standby mode and stayed there.This was noticed between 11:50am - 12:50pm at 12:45 a simulator was attached for testing.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor discharged a patient on its own and went straight into standby mode and stayed there.This was noticed between 11:50am - 12:50pm at 12:45 a simulator was attached for testing.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.Additional device information: d10: concomitant medical device: central nurse's station model: pu-681ra sn: (b)(6).
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor discharged a patient on its own and went straight into standby mode and stayed there.This was noticed between 11:50am - 12:50pm at 12:45 a simulator was attached for testing.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.Additional device information: d10: concomitant medical device: central nurse's station.Model: pu-681ra.Sn: (b)(6).Corrected information: a1 patient identifier.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor discharged a patient on its own and went straight into standby mode and stayed there.This was noticed between 11:50am - 12:50pm at 12:45 a simulator was attached for testing.No patient harm was reported.

• 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: 24510143
• Report Number: 8030229-2026-00000
• Device Sequence Number: 21446766
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: (01)04931921103517
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/10/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 02/20/2026; 06/08/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/04/2026; 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2022
• 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: PU-681RA SN (B)(6); PU-681RA SN (B)(6)
• Patient Sex: Unknown