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 bedside monitor (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 #: (b)(6) device manufacturer data: ni unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported on 11/04/2025 that this bedside monitor (bsm) was randomly rebooting.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported on (b)(6) 2025 that this bedside monitor (bsm) was randomly rebooting.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported on (b)(6) 2025 that this bedside monitor (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.

• 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: 23658960
• Report Number: 8030229-2025-05872
• Device Sequence Number: 13292811
• 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: 05/29/2015
• 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