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

Model Number	MU-671RA
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported on 11/04/2025 that this bsm was randomly rebooting.No patient harm was reported.The bme said they move the bsm-1733's around and would not know which one was connected to the main bsm at the time the original issue occurred.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: the following device was used in conjunction with the bsm: bedside monitor (bsm-1733) model #: bsm-1733a serial #: ni device manufacturer data: ni unique identifier (udi) #: (b)(4).Returned to nihon kohden:.
Event or Problem Description
The biomedical engineer (bme) reported on 11/04/2025 that this bsm was randomly rebooting.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported on 11/04/2025 that this bsm was randomly rebooting.No patient harm was reported.The bme said they move the bsm-1733's around and would not know which one was connected to the main bsm at the time the original issue occurred.Investigation summary: after the logs were reviewed for randomly rebooting; nihon kohden corporation (nkc) confirmed that these incidents were caused by software issues.A release of the countermeasure software ver.08-97 is in progress.Trending will continue to be monitored for this device, incidents, issues, and causes.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: bedside monitor (bsm-1733) model #: bsm-1733a serial #: ni device manufacturer data: ni unique identifier (udi) #: (b)(4).Returned to nihon kohden: na additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h11 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported on 11/04/2025 that this bsm was randomly rebooting.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: 23658623
• Report Number: 8030229-2025-05871
• Device Sequence Number: 10055101
• Product Code: MHX
• UDI-Device Identifier: 04931921103562
• UDI-Public: (01)04931921103562
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 12/31/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BSM (BSM-1733); BSM (BSM-1733)
• Patient Sex: Unknown