MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NIHON KOHDEN LIFE SCOPE G7 BEDSIDE MONITORING SYSTEM

Model Number	CU-172R
Medical Device Problem Codes	Tactile Prompts/Feedback (4022); No Tactile Prompts/Feedback (4024)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse reported that the touchscreen on the g7 monitor was unresponsive.It also displayed an "input unit disconnect" error message at the central nurse's station (cns).No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the nurse reported that the touchscreen on the g7 monitor was unresponsive.It also displayed an "input unit disconnect" error message at the central nurse's station (cns).Technical support (ts) had her use a mouse to attempt to reboot the device, but she could not.The mouse was jittering around and would not allow her to click the power off confirmation.She planned to call back with their biomed but never did.No response was received after multiple attempts to follow up were made to the customer.No patient harm was reported.Investigation summary: initial troubleshooting was ineffective, and nihon kohden requested involvement from the customer's biomed to reboot the device.Multiple attempts were made to collect additional information regarding the complaint.Upon follow up, the customer confirmed that the issue had been resolved but did not provide further details.As such, a definitive cause for the event could not be determined.A review of the device's complaint history by serial number reveals no similar issues.Nihon kohden will continue to trend and monitor.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h11 additional manufacturer narrative.

• Brand Name: NIHON KOHDEN LIFE SCOPE G7 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: 25817151
• Report Number: 8030229-2026-06843
• Device Sequence Number: 6064763
• Product Code: MHX
• UDI-Device Identifier: 04931921004517
• UDI-Public: (01)04931921004517
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/14/2026

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-172R
• Device Catalogue Number: CU-172R
• 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: 06/21/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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