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

Model Number	MU-631RA
Medical Device Problem Codes	Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) had a white display screen with lines all over it.The device was on an arm and was not accessible to anyone.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.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) had a white display screen with lines all over it.The device was on an arm and was not accessible to anyone.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) had a white display screen with lines all over it.The device was on an arm and was not accessible to anyone.No patient harm was reported.Investigation summary: the reported device was returned for repair.The unit was evaluated, and the complaint was duplicated.The cause was determined to be a circuit board failure.A complaint history review for the bsm-6000 did not show any trend for this issue.Trending will continue to be monitored for this device, incidents, issues, and causes.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 06/03/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 06/10/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 06/19/2025 emailed the customer via microsoft outlook for all information in the ni list above: the customer replied but did not provide the requested device information.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes.H11 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) had a white display screen with lines all over it.The device was on an arm and was not accessible to anyone.

• 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: 22302422
• Report Number: 8030229-2025-05033
• Device Sequence Number: 9311526
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: (01)04931921103517
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/10/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.
• Patient Sex: Unknown