MAUDE Adverse Event Report: Nihon Kohden Corporation Nihon Kohden Life Scope G5 Bedside Monitoring System

Model Number	CU-152R
Medical Device Problem Codes	Unable to Obtain Readings (1516); Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient death: the biomedical engineer (biomed) reported that the g5 monitor gave a "no spo2 probe connected" error message and would not pick up spo2 levels.He had tried rebooting the device and changing the spo2 cable, but the issue persisted.He also tested the original cable on another device, and it worked as expected.This occurred while the patient was coding.Although the patient passed away, the onsite "house super," who was called by ts later, stated they did not believe the spo2 issue was the cause of the patient's death.Additional troubleshooting was performed with the house super, and the troubleshooting results seemed to point to the spo2 cable as the problem and not the monitor.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 was used in conjunction with the g5 monitor: central nurse's station (cns): model #: cns- 2101 serial #: (b)(6) device manufacturer data: 05/14/2025 unique identifier (udi) #: (b)(4) returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (biomed) reported that the g5 monitor gave a "no spo2 probe connected" error message and would not pick up spo2 levels.This occurred while the patient was coding.Although the patient passed away, the onsite "house super," who was called by ts later, stated they did not believe the spo2 issue was the cause of the patient's death.
Event or Problem Description
The biomedical engineer (biomed) reported that the g5 monitor gave a "no spo2 probe connected" error message and would not pick up spo2 levels.This occurred while the patient was coding.Although the patient passed away, the onsite "house super," who was contacted by ts later stated they did not believe the spo2 issue was the cause of the patient's death.
Additional Manufacturer Narrative
Patient death: details of complaint: the biomedical engineer (biomed) reported that the g5 monitor gave a "no spo2 probe connected" error message and would not pick up spo2 levels.He had tried rebooting the device and changing the spo2 cable, but the issue persisted.He also tested the original cable on another device, and it worked as expected.This occurred while the patient was coding.Although the patient passed away, the onsite "house super," who was contacted by ts later stated they did not believe the spo2 issue was the cause of the patient's death.Additional troubleshooting was performed with the house super, and the troubleshooting results seemed to point to the spo2 cable as being the problem and not the nk monitor.Investigation summary: upon follow up, the customer declined further investigation.The customer did not believe that the device contributed to the patient's death.Further troubleshooting by the customer confirmed that spo2 monitoring was working on the device, and the failure was isolated to the cable.The device was functioning appropriately by displaying a technical message.The cause of the reported spo2 issue was the spo2 cable.The cables are consumables that require periodic replacement.A review of the device's complaint history by serial number reveals no similar issues.Nihon kohden will continue to trend and monitor.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2-a6.B6-b7.Attempt # 1: (b)(6) 2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 3: (b)(6) 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.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the g5 monitor: central nurse's station (cns): model #: cns- 2101, serial #: (b)(6), device manufacturer data: 05/14/2025, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.

• Brand Name: Nihon Kohden Life Scope G5 Bedside Monitoring System
• 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: 25879252
• Report Number: 8030229-2026-06887
• Device Sequence Number: 8046790
• Product Code: MHX
• UDI-Device Identifier: 04931921002056
• UDI-Public: (01)04931921002056
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K203435
• 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): 10/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CU-152R
• Device Catalogue Number: CU-152R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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: Central Nurse's Station (b)(6).
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown