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

Model Number	CU-151R
Medical Device Problem Codes	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	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the touchscreen was completely unresponsive when pressed.The issue was discovered by clinical staff during patient use.It is unclear whether the vitals were still able to be monitored or if the whole unit froze.The customer has been unresponsive to correspondences.There was no harm 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.
Event or Problem Description
The customer reported that the touchscreen was completely unresponsive when pressed.The issue was discovered by clinical staff during patient use.It is unclear whether the vitals were still able to be monitored or if the whole unit froze.The customer has been unresponsive to correspondences.There was no harm reported.
Event or Problem Description
The customer reported that the touchscreen was completely unresponsive when pressed.The issue was discovered by clinical staff during patient use.It is unclear whether the vitals were still able to be monitored or if the whole unit froze.The customer has been unresponsive to correspondences.There was no harm reported.
Additional Manufacturer Narrative
The customer reported that the touchscreen was completely unresponsive when pressed.The issue was discovered by clinical staff during patient use.It is unclear whether the vitals were still able to be monitored or if the whole unit froze.The customer has been unresponsive to correspondences.There was no harm reported.Investigation conclusion: the complaint device was received.The unit was evaluated and the complaint was duplicated.The cause was determined to be a touch panel failure.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: 10/07/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 10/09/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 10/13/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.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.

• 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: 23330611
• Report Number: 8030229-2025-05672
• Device Sequence Number: 10612484
• Product Code: MHX
• UDI-Device Identifier: 04931921002018
• UDI-Public: (01)04931921002018
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/23/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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