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

Model Number	CU-192R
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	01/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the touchscreen on the g9 monitor was not working.Technical support (ts) had the bme run the driver setup and touchscreen calibration per the service manual, but when attempting to calibrate, it could not find the touchscreen controller.When they went into the galax tool to try to manually configure the touchscreen, it would not recognize the controller at com3.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 on the g9 monitor was not working.Technical support (ts) had the bme run the driver setup and touchscreen calibration per the service manual, but when attempting to calibrate, it could not find the touchscreen controller.When they went into the galax tool to try to manually configure the touchscreen, it would not recognize the controller at com3.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the touchscreen on the g9 monitor was not working.Technical support (ts) had the bme run the driver setup and touchscreen calibration per the service manual, but when attempting to calibrate, it could not find the touchscreen controller.When they went into the galax tool to try to manually configure the touchscreen, it would not recognize the controller at com3.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the touchscreen on the g9 monitor was not working.Technical support (ts) had the bme run the driver setup and touchscreen calibration per the service manual, but when attempting to calibrate, it could not find the touchscreen controller.When they went into the galax tool to try to manually configure the touchscreen, it would not recognize the controller at com3.No patient harm was reported.Investigation summary: the g9 monitor was returned to nihon kohden (nk) for evaluation and repair.During the evaluation, the reported issue was successfully duplicated.The cause was determined to be corruption of the operating system.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: 01/05/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 01/12/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 3: 01/22/2026 emailed the customer via microsoft outlook for the information in the ni list above: the customer replied on the 3rd attempt, but did not provide the requested information.Additional information: b4 date of this report 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: 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: 24180139
• Report Number: 8030229-2026-06145
• Device Sequence Number: 9557406
• Product Code: MHX
• UDI-Device Identifier: 04931921112168
• UDI-Public: (01)04931921112168
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/01/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• 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