BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELEVISION MONITOR

    MDR report key: 1559381 · Received December 9, 2009

    Report

    Report Number
    MW5013908
    Event Type
    Death
    Date Received
    December 9, 2009
    Date of Event
    October 11, 2009
    Report Date
    December 9, 2009
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN V-TACH AND MONITOR DID NOT ALARM AT NURSING STATION. NURSE WAS CHARTING AT NURSING STATION AND LOOKED AT MONITOR TO FIND PATIENT IN V-TACH. STAFF RESPONDED TO PATIENT'S NEEDS. FAMILY CHOSE TO MAKE PATIENT DNR AND PATIENT EXPIRED. UNKNOWN WHY MONITOR DID NOT ALARM. MFR WAS CONTACTED. THIS EVENT AND TESTING OCCURRED BUT NO DUPLICATION OR ERROR COULD BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEVISION MONITOR CARDIAC MONITOR MHX NIHON KOHDEN AMERICA, INC. BSM-5106A 142967

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death