BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL MEDICAL CORPORATION

    MDR report key: 2668940 · Received July 11, 2012

    Report

    Report Number
    2668940
    Event Type
    Death
    Date Received
    July 11, 2012
    Date of Event
    July 6, 2012
    Report Date
    July 9, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EMS CREW RESPONDED TO A RESIDENCE WITH REPORT OF CARDIAC ARREST. PLACED THE PT ON THE ZOLL E-SERIES CARDIAC MONITOR / PACEMAKER / DEFIBRILLATOR AND FOUND THE PT TO BE IN ASYSTOLE. THE CREW TREATED THE PT AND SAW A CHANGE IN RHYTHM TO VENTRICULAR FIBRILLATION. THE CREW CHARGE THE MONITOR AND ATTEMPTED TO DELIVER DEFIBRILLATION. THE MONITOR DID NOT APPEAR TO ADMINISTER THE SHOCK, THEN OVERHEATED, SMOKING, AND HOT ENOUGH THAT ONE RESCUER SUFFERED A FIRST DEGREE BURN TO THEIR ARM CARRYING THE UNIT OUT OF THE HOUSE. THE CREW USED AN ALTERNATIVE DEVICE IN THE FORM OF AN AED TO DELIVER THE NECESSARY DEFIBRILLATION, BUT THERE WAS A BRIEF DELAYING RETRIEVING THE ITEM FROM ONE OF THE VEHICLES OUTSIDE THE PT'S RESIDENCE. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MEDICAL CORPORATION MKJ ZOLL MEDICAL CORPORATION E-SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death