MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION LIFE SCOPE G9; BEDSIDE MONITOR

Model Number	CU-192R
Medical Device Problem Codes	Communication or Transmission Problem (2896); Output Problem (3005); Wireless Communication Problem (3283); No Tactile Prompts/Feedback (4024)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the touchscreen and mouse on the g9 monitor were not working.They also reported that the device gave a "comm loss" error message.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the touchscreen and mouse on the g9 monitor were not working.They also reported that the device gave a "comm loss" error message.No patient harm was 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 biomedical engineer (bme) reported that the touchscreen and mouse on the g9 monitor were not working.They also reported that the device gave a "comm loss" error message.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the touchscreen and mouse on the g9 monitor were not working.They also reported that the device gave a "comm loss" error message.No patient harm was reported.Investigation summary: the g9 monitor will not be returned to nihon kohden (nk) for evaluation.As such, the complaint could not be confirmed, and a root cause could not be determined.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: 01/28/2026 emailed the customer via microsoft outlook for the information in the ni list above: the customer replied, stating that the requested information cannot be provided.

• Brand Name: LIFE SCOPE G9
• 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: 24402313
• Report Number: 8030229-2026-06242
• Device Sequence Number: 10113358
• Product Code: MHX
• UDI-Device Identifier: 04931921112168
• UDI-Public: (01)04931921112168
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K213316
• 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): 04/20/2026

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-192R
• Device Catalogue Number: CU-192RA
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2019
• 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