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

Model Number	MU-631RA
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that they have had complaints from the er on this monitor for the last two weeks.Staff complained that the unit reboots, we blocked the room and attached simulator at let it run for three hours with no issues.Next time the staffed complained, the bme removed the monitor and brought it to the shop, hooked up a simulator at let unit run for 24 hours with no issues.Both times they returned to er.On (b)(6) 2025, staff complained again about the unit turning off.The bme went to the room and discovered that the unit reboots.When it comes on, it produces a screen full of information, then reboots.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that they have had complaints from the er on this monitor for the last two weeks.Staff complained that the unit reboots, we blocked the room and attached simulator at let it run for three hours with no issues.Next time the staffed complained, the bme removed the monitor and brought it to the shop, hooked up a simulator at let unit run for 24 hours with no issues.Both times they returned to er.On (b)(6) 2025, staff complained again about the unit turning off.The bme went to the room and discovered that the unit reboots.When it comes on, it produces a screen full of information, then reboots.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.Additional device information: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device bedside monitor, model: bsm-1753a, sn: ni.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that they have had complaints from the er on this monitor for the last two weeks.Staff complained that the unit reboots, we blocked the room and attached simulator at let it run for three hours with no issues.Next time the staffed complained, the bme removed the monitor and brought it to the shop, hooked up a simulator at let unit run for 24 hours with no issues.Both times they returned to er.On (b)(6) 2025, staff complained again about the unit turning off.The bme went to the room and discovered that the unit reboots.When it comes on, it produces a screen full of information, then reboots.No patient harm was reported.Investigation conclusion: the biomedical engineer (bme) reported intermittent reboot issues with a device (mu-631ra, sn: (b)(6)).The unit was returned for evaluation and repair.The evaluation confirmed the complaint and identified malfunction in the main digital board as the root cause.The unit underwent 24 hours of extended testing and operated to manufacturer's specifications after replacement of the malfunctioning board.Additional device information: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device.Attempt #1 09/23/2025 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the additional device information as requested.Bedside monitor.Model: bsm-1753a.Sn: ni.Additional information: b4 date of this report.D9 device available for evaluation.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 they have had complaints from the er on this monitor for the last two weeks.Staff complained that the unit reboots, we blocked the room and attached simulator at let it run for three hours with no issues.Next time the staffed complained, the bme removed the monitor and brought it to the shop, hooked up a simulator at let unit run for 24 hours with no issues.Both times they returned to er.On (b)(6) 2025, staff complained again about the unit turning off.The bme went to the room and discovered that the unit reboots.When it comes on, it produces a screen full of information, then reboots.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: 23129252
• Report Number: 8030229-2025-05532
• Device Sequence Number: 21154002
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: (01)04931921103517
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/29/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• 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: BSM-1753A SN NI; BSM-1753A SN NI
• Patient Sex: Unknown