BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 1063083 · Received June 11, 2008

    Report

    Report Number
    1063083
    Event Type
    Death
    Date Received
    June 11, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 10, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILURE TO RESCUE A MORBIDLY OBESE PATIENT. A MORBIDLY OBESE PATIENT WITH NON-ST ELEVATION MYOCARDIAL INFARCTION STATUS POST CARDIAC CATHETERIZATION, PLACEMENT OF STENT X2 WHEN HE HAD A CARDIAC ARREST. TEN DEFIBRILLATION ATTEMPTS WERE MADE WITH THE ZOLL M SERIES BIPHASIC DEFIBRILLATOR AT 200 JOULES (THE MAX) AND HANDS FREE PADS ANTERIOR / POSTERIOR PLACEMENT. UNABLE TO RESCUE PATIENT. ANOTHER MANUFACTURER'S BIPHASIC DEVICE WAS OBTAINED AND THE PATIENT WAS SHOCKED X1 WITH 360 JOULES WHICH RESULTED IN CONVERSION TO A PERFUSING RHYTHM. THE ZOLL M SERIES DEFIBRILLATOR WAS FULLY CHECKED AFTER THIS EVENT AND IS WORKING TO SPECIFICATION. THIS IS THE SECOND EVENT WE HAVE SEEN OF A FAILURE TO RESCUE A MORBIDLY OBESE PATIENT WITH A BIPHASIC DEVICE AT THE MAXIMUM CAPACITY 200 JOULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR, EXTERNAL, BIPHASIC MKJ ZOLL MEDICAL CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death CARDIAC DRUGS| OTHER| CARDIAC DRUGS| OTHER