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); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction

• 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: 25803488
• Report Number: 8030229-2026-06840
• Device Sequence Number: 15703219
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: (01)04931921103517
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/30/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2020
• 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
• Patient Sex: Unknown