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

Model Number	MU-671RA
Medical Device Problem Codes	Device Alarm System (1012); No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this unit failed to alarm for arrhythmia.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that this unit failed to alarm for arrhythmia.According to the customer, the unit is alarming; however, there's no sound and no led indicator.Per the customer, the unit has no sound.The nurse was in the room when the device should have alarmed.The customer replaced the unit with a spare.The customer tested the unit in their shop, and they were able to recreate the issue.There was no patient injury 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.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 06/02/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 06/04/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 06/11/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this unit failed to alarm for arrhythmia.According to the customer, the unit is alarming; however, there's no sound and no led indicator.Per the customer, the unit has no sound.The nurse was in the room when the device should have alarmed.The customer replaced the unit with a spare.The customer tested the unit in their shop, and they were able to recreate the issue.There was no patient injury reported.Investitgation summary: the returned unit was evaluated and the reported complaint was duplicated.The root cause was determined to be a circuit board failure.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? h11 additional manufacturer narrative.
Event or Problem Description
The customer reported that this unit failed to alarm for arrhythmia.There was no patient injury 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: 22233151
• Report Number: 8030229-2025-04983
• Device Sequence Number: 8176928
• Product Code: MHX
• UDI-Device Identifier: 04931921103562
• UDI-Public: (01)04931921103562
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/11/2025

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-671RA
• Device Catalogue Number: MU-671RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2011
• 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