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

Model Number	MU-631RA
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this bedside monitor (bsm) is not showing up in the central nurse's station (cns).There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that this bedside monitor (bsm) is not showing up in the central nurse's station (cns).According to the customer, all the selections and information were grayed out.The customer removed and re-docked the transport monitor, powered down the main monitor and checked that the cable was plugged in; however, the issue remained.Technical support (ts) informed the customer that there definitely appears to be a connection issue.Ts asked the customer to have their biomed reach out to do a deeper troubleshooting.The patient was moved to a different room.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: 12/10/2025 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 bedside monitor (bsm) is not showing up in the central nurse's station (cns).According to the customer, all the selections and information were grayed out.The customer removed and re-docked the transport monitor, powered down the main monitor and checked that the cable was plugged in; however, the issue remained.Technical support (ts) informed the customer that there definitely appears to be a connection issue.Ts asked the customer to have their biomed reach out to do a deeper troubleshooting.The patient was moved to a different room.There was no patient injury reported.Investigation summary: the device with the reported issue was not returned for evaluation; therefore, a root cause could not be determined.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 12/03/2025 i called patti to ask if the reported issue has been resolved and if resolved, how it was resolved.A message was left for patti to call me back with this information.Attempt # 2: 12/05/2025 i called patti to ask if the reported issue has been resolved and if resolved, how it was resolved.A message was left for patti to call me back with this information.Attempt # 3: 12/10/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h11 additional manufacturer narrative.
Event or Problem Description
The customer reported that this bedside monitor (bsm) is not showing up in the central nurse's station (cns).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: 23768871
• Report Number: 8030229-2025-05931
• Device Sequence Number: 10594456
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: (01)04931921103517
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2015
• 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
• Patient Sex: Unknown