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

Model Number	CU-192R
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the g9 monitor shut down during a case.Vitals continued to be monitored on the transport monitor.The bme was unable to duplicate the issue during troubleshooting.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.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the g9 monitor: bedside monitor (bsm): model #: bsm-1753a, serial #: (b)(6), device manufacturer data: 03/23/2017, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported that the g9 monitor shut down during a case.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the g9 monitor shut down during a case.Vitals continued to be monitored on the transport monitor.The bme was unable to duplicate the issue during troubleshooting.No patient harm was reported.Investigation summary: the g9 monitor was returned to nihon kohden for evaluation and repair.The reported issue could not be duplicated after 10 days of testing.There were no instances of spontaneous shutdowns or interruptions of data flow.The device's software was updated from version 01-36 to the latest version, 01-48, to ensure optimal performance.Since the malfunction was not duplicated, the root cause cannot be definitively established.The device experienced system updates during boot up that prompted several reboots before the g9 application launched successfully.It is possible that the update reboots were misinterpreted as a power issue.Possible other causes may include an inadequate power source or issues with any connected uninterruptible power supply (ups) at the time of the complaint.A review of the device's complaint history by serial number reveals one similar complaint, ticket (b)(4).It was reported that the device would attempt to boot and then shut off, but the issue was not duplicated during that evaluation.Nihon kohden will continue to trend and monitor.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the g9 monitor: bedside monitor (bsm): model #: bsm-1753a.Serial #: (b)(6).Device manufacturer data: 03/23/2017.Unique identifier (udi) #: 04931921111871.Returned to nihon kohden: na.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.
Event or Problem Description
The biomedical engineer (bme) reported that the g9 monitor shut down during a case.No patient harm was reported.

• 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: 23373246
• Report Number: 8030229-2025-05704
• Device Sequence Number: 9950386
• Product Code: MHX
• UDI-Device Identifier: 04931921112168
• UDI-Public: (01)04931921112168
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 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-192R
• Device Catalogue Number: CU-192RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BSM (BSM-1753A); BSM (BSM-1753A)
• Patient Sex: Unknown