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

Model Number	CU-192R
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	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this unit got stuck in a boot loop.The unit was not in patient use at the time.
Additional Manufacturer Narrative
The customer reported that this unit got stuck in a boot loop.The unit displayed a system board failure graph error message.The issue was discovered during setup.The customer tried to reboot the unit; however, the unit would not boot up at all.The unit was not in patient use at the time.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 Manufacturer Narrative
Details of complaint: the customer reported that this unit got stuck in a boot loop.The unit displayed a system board failure graph error message.The issue was discovered during setup.The customer tried to reboot the unit; however, the unit would not boot up at all.The unit was not in patient use at the time.Investigation summary: the device with the reported issue was returned for evaluation.During the evaluation, the reported issue was duplicated.The root ccause for the reported issue was determined to be a circuit board failure of the motherboard.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10.Attempt # 1: 01/27/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 01/30/2026 i called mouhammed to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for mouhammed to call me back with this information.Attempt # 3: 02/02/2026 i called mouhammed to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for mouhammed to call me back with this information.Additional information: b4 date of this report.D9 is this device available for evaluation? g3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h3 device evaluated by manufacturer? h11 additional manufacturer narrative.
Event or Problem Description
The customer reported that this unit got stuck in a boot loop.The unit was not in patient use at the time.

• 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: 24268727
• Report Number: 8030229-2026-06137
• Device Sequence Number: 10031271
• 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): 04/30/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2020
• 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