MAUDE Adverse Event Report: Nihon Kohden Corporation Life Scope TR; Bedside Monitor

Model Number	MU-651RA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/12/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that they had a patient death while they were connected to this monitor.It appears that the patient was not admitted to this bedside monitor (bsm) at all or at least not correctly.They have no full disclosure data at the central nurse's station (cns) or bedside monitor (bsm), and the patient name/ mrn is not in the discharged patients list, even though there are discharges from longer ago than this incident in that list and there was no patient data going to epic emr.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.Central nurse's station model: pu-681ra sn: (b)(6).
Event or Problem Description
The biomedical engineer (bme) reported that they had a patient death while they were connected to this monitor.It appears that the patient was not admitted to this bedside monitor (bsm) at all or at least not correctly.They have no full disclosure data at the central nurse's station (cns) or bedside monitor (bsm), and the patient name/ mrn is not in the discharged patients list, even though there are discharges from longer ago than this incident in that list and there was no patient data going to epic emr.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that they had a patient death while they were connected to this monitor.It appears that the patient was not admitted to this bedside monitor (bsm) at all or at least not correctly.They have no full disclosure data at the central nurse's station (cns) or bedside monitor (bsm), and the patient name/ mrn is not in the discharged patients list, even though there are discharges from longer ago than this incident in that list and there was no patient data going to epic emr.Investigation conclusion: multiple attempts have been made to retrieve bsm and cns logs.However, there was no response received.Therefore, this complaint could not be confirmed, and the root cause of the reported issue could not be determined.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6: patient information.B6 - b7: relevant test / laboratory data, other relevant (patient history).Attempt #1: (b)(6) 2026 emailed customer for all items under the no information section.No reply was received.Attempt #2: (b)(6) 2026: emailed customer for all items under the no information section.No reply was received.Attempt #3: (b)(6) 2026: emailed customer for all items under the no information section.No reply was received.Additional device information: d10 concomitant medical device.Central nurse's station: model: pu-681ra, sn: (b)(6).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 they had a patient death while they were connected to this monitor.It appears that the patient was not admitted to this bedside monitor (bsm) at all or at least not correctly.They have no full disclosure data at the central nurse's station (cns) or bedside monitor (bsm), and the patient name/ mrn is not in the discharged patients list, even though there are discharges from longer ago than this incident in that list and there was no patient data going to epic emr.

• Brand Name: Life Scope TR
• 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: 25422538
• Report Number: 8030229-2026-06642
• Device Sequence Number: 21362084
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: (01)04931921103548
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• 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): 08/14/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MU-651RA
• Device Catalogue Number: MU-651RA
• 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: 05/15/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 06/07/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PU-681RA, SN (b)(6).
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown