MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NIHON KOHDEN LIFE SCOPE G5 BEDSIDE MONITORING SYSTEM

Model Number	CU-151R
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Application Program Problem (2880); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this g5 was stuck in a boot loop and not displaying any content.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that this g5 was stuck in a boot loop and not displaying any content.The customer tried rebooting the unit and ran it on battery power; however, it wouldn't start up.After the customer reconnected the power cable, the unit rebooted; however, it didn't display any content.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: 12/08/2025 emailed the customer via microsoft outlook for all information in the ni list above: the customer replied and stated that no other devices were connected to this unit.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this g5 was stuck in a boot loop and not displaying any content.The customer tried rebooting the unit and ran it on battery power; however, it wouldn't start up.After the customer reconnected the power cable, the unit rebooted; however, it didn't display any content.There was no patient injury reported.Investigation summary: the device with the reported issue was returned for evaluation.The reported issue was duplicated during the evaluation of the unit.The root cause of the reported issue was determined to be a circuit board failure of the main board.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 12/08/2025 emailed the customer via microsoft outlook for all information in the ni list above: the customer replied and stated that no other devices were connected to this unit.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 g5 was stuck in a boot loop and not displaying any content.There was no patient injury reported.

• Brand Name: NIHON KOHDEN LIFE SCOPE G5 BEDSIDE MONITORING SYSTEM
• 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: 23863799
• Report Number: 8030229-2025-05924
• Device Sequence Number: 9350254
• Product Code: MHX
• UDI-Device Identifier: 04931921002018
• UDI-Public: (01)04931921002018
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203435
• 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): 03/17/2026

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: CU-151R
• Device Catalogue Number: CU-151R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2024
• 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: NOT APPLICABLE (N/A); NOT APPLICABLE (N/A)
• Patient Sex: Unknown