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

Model Number	CU-151R
Medical Device Problem Codes	Computer Software Problem (1112); Output Problem (3005); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that touchscreen for the bedside monitor (bsm) was unresponsive.The bme tried connecting a mouse to attempt to calibrate the touchscreen, but it was not responsive.When first trying to evaluate the monitor, the bme had his fingers around the beige portion of the frame and heard a tone that sounded like a touch response, but a menu popped up and he was unable to x out of that.Rebooting the monitor without the power cord did not resolve the issue.There was no patient harm reported.Investigation summary: the reported device was sent in for evaluation and repair and the reported problem was duplicated.Additionally, after 3-4 hours of burn in, the device unexpectedly shut down and would not power back on.This device had a failing main board and the repair is currently not possible.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.
Event or Problem Description
The biomedical engineer (bme) reported that touchscreen for the bedside monitor (bsm) was unresponsive.The bme tried connecting a mouse to attempt to calibrate the touchscreen, but it was not responsive.When first trying to evaluate the monitor, the bme had his fingers around the beige portion of the frame and heard a tone that sounded like a touch response, but a menu popped up and he was unable to x out of that.Rebooting the monitor without the power cord did not resolve the issue.There was no patient harm 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: 22349427
• Report Number: 8030229-2025-05108
• Device Sequence Number: 9024737
• 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
• 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-151R
• Device Catalogue Number: CU-151R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• 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: 01/11/2022
• 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