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

Model Number	MU-671RA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse reported that while the bis is connected to the bedside monitor, it is not displaying a numeric value on the bis, and the waveform intermittently disappears.They stated they had already swapped out both the bis module and the connecting cable, but the issue persists.The setup includes a dau connected to a bsm-6000.Tech support (ts) advised that since replacing the bis and cable did not resolve the issue, further troubleshooting would be required by biomed.Recommended checking or swapping the dau, bsm, or transport unit.No patient harm was reported.
Additional Manufacturer Narrative
The nurse reported that while the bis is connected to the bedside monitor, it is not displaying a numeric value on the bis, and the waveform intermittently disappears.They stated they had already swapped out both the bis module and the connecting cable, but the issue persists.The setup includes a dau connected to a bsm-6000.Tech support (ts) advised that since replacing the bis and cable did not resolve the issue, further troubleshooting would be required by biomed.Recommended checking or swapping the dau, bsm, or transport unit.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: 24867315
• Report Number: 8030229-2026-06478
• Device Sequence Number: 18778898
• Product Code: MHX
• UDI-Device Identifier: 04931921103562
• UDI-Public: (01)04931921103562
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2026

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-671RA
• Device Catalogue Number: MU-671RA
• 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: 04/04/2026
• Supplement Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2017
• 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
• Patient Sex: Unknown