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

Model Number	CU-152R
Medical Device Problem Codes	No Display/Image (1183); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the rear hdmi port was not sending data to the display screen.Swapping the monitor for another one that was configured identically allowed the secondary display to work with no issues.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the rear hdmi port was not sending data to the display screen.Swapping the monitor for another one that was configured identically allowed the secondary display to work with no issues.The device was not in patient use at the time.Investigation summary: the reported device was sent in for evaluation and repair and the reported problem was duplicated.The cause of the issue was circuit board failure.No further investigation will be performed.Nk will continue to monitor and trend.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 06/03/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 06/10/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 06/19/2025 emailed the customer via microsoft outlook for all information in the ni list above: the customer replied that none of the requested information can be provided.

• 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: 22350579
• Report Number: 8030229-2025-05109
• Device Sequence Number: 20964226
• Product Code: MHX
• UDI-Device Identifier: 04931921002056
• UDI-Public: (01)04931921002056
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 06/27/2025

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: CU-152R
• Device Catalogue Number: CU-152R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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