BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPONDER 1500

    MDR report key: 40927 · Received September 10, 1996

    Report

    Report Number
    2124823-1996-00008
    Event Type
    Malfunction
    Date Received
    September 10, 1996
    Date of Event
    June 6, 1996
    Report Date
    August 12, 1996
    Manufacturer
    MARQUETTE ELECTRONICS, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGES BATTERY FAILED DURING A MEDICAL EMERGENCY ON BOARD A SHIP RESULTING IN PT DEATH. REPEATED ATTEMPTS BY MFR TO OBTAIN ADD'L EVENT AND PT DETAILS HAVE BEEN UNSUCCESSFUL. CUSTOMER STATES THIS DID NOT CAUSE OR CONTRIBUTE TO PT OUTCOME. MANUFACTURER'S RECORDS INDICATE BATTERY IN QUESTION WAS BEYOND RECOMMENDED USEFUL LIFE AS STATED IN DEVICE LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPONDER 1500 DEFIBRILLATOR D.C MKJ MARQUETTE ELECTRONICS, INC. 1500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN