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

Model Number	CU-192R
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the graph on the left side of the monitor displaying the numerical values of the ecg, heart rate and spo2 intermittently go out.Technical support (ts) asked the customer if the box would entirely disappear or if it was just the numerical values.The customer was unsure if it was the entire box or just the numerical values disappearing.The customer was not in front of the unit and the unit was being used at the time.The customer will connect the unit to a simulator and will reach out to provide a video of the issue.There was no patient injury 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 customer reported that the graph on the left side of the monitor displaying the numerical values of the ecg, heart rate and spo2 intermittently go out.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the graph on the left side of the monitor displaying the numerical values of the ecg, heart rate and spo2 intermittently go out.Technical support (ts) asked the customer if the box would entirely disappear or if it was just the numerical values.The customer was unsure if it was the entire box or just the numerical values disappearing.The customer was not in front of the unit and the unit was being used at the time.The customer will connect the unit to a simulator and will reach out to provide a video of the issue.There was no patient injury reported.Investigation summary: the device with the reported issue was not returned for evaluation as according to the customer, the issue resolved on its own.A root cause could not be determined.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 10/30/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 10/31/2025 i called ken to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for ken to call me back with this information.Attempt # 3: 11/04/2025 i called ken to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for ken to call me back with this information.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h11 additional manufacturer narrative.
Event or Problem Description
The customer reported that the graph on the left side of the monitor displaying the numerical values of the ecg, heart rate and spo2 intermittently go out.There was no patient injury 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: 23487633
• Report Number: 8030229-2025-05683
• Device Sequence Number: 16077160
• Product Code: MHX
• UDI-Device Identifier: 04931921112168
• UDI-Public: (01)04931921112168
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/26/2026

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: 10/13/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2020
• 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