BEUDAMED
    FDA Adverse Event Death Summary report: N

    PU-681RA

    MDR report key: 22015277 · Received May 13, 2025

    Report

    Report Number
    8030229-2025-04950
    Event Type
    Death
    Date Received
    May 13, 2025
    Date of Event
    July 3, 2024
    Report Date
    May 13, 2025
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE PATIENT PASSED AWAY WHILE BEING MONITORED AT THE CENTRAL NURSE'S STATION (CNS). THEY REQUESTED AN INVESTIGATION ON THE LOGS FROM THE DEVICES IN USE AT THE TIME OF DEATH. IT WAS FOUND THAT AN ASYSTOLE OCCURRED AT THE RELEVANT TIME. INVESTIGATION SUMMARY: THE DEVICE LOGS AND ECG PRINTS WERE REVIEWED BY NKC UNDER (B)(4). IT WAS FOUND THAT THE DEVICE ALARMED APPROPRIATELY FOR ASYSTOLE AT THE TIME OF THE PATIENT EVENT, AND THAT THE USER SILENCED THE ALARM. NK WILL CONTINUE TO MONITOR AND TREND. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS: TELEMETRY TRANSMITTER: MODEL #: ZM-531PA SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 09/25/2020 UNIQUE IDENTIFIER (UDI) #: (B)(4) RETURNED TO NIHON KOHDEN: NA.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PATIENT PASSED AWAY WHILE BEING MONITORED AT THE CENTRAL NURSE'S STATION (CNS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182956 PU-681RA CENTRAL MONITORING SYSTEM MHX NIHON KOHDEN CORPORATION PU-681RA NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Death TELEMETRY TRANSMITTER