BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1933746 · Received December 16, 2010

    Report

    Report Number
    3015876-2010-01379
    Event Type
    Death
    Date Received
    December 16, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 17, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE; HOWEVER, THE REPORTED FAILURE WAS NOT DUPLICATED. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. A CLINICAL REVIEW OF THE REPORTED EVENT DETERMINED THAT THE DEVICE USE MAY HAVE CONTRIBUTED TO THE PT'S OUTCOME. THE ECG RHYTHM WAS SHOWING AS VENTRICULAR FIBRILLATION (VF) AND THE DEVICE WAS CHARGED THREE SEPARATE TIMES, BUT EACH CHARGE WAS REMOVED RATHER THAN DELIVERED TO THE PT. THE CUSTOMER BELIEVES THAT THE ENERGY SELECT BUTTON WAS PRESSED BY AN INTERN USER RATHER THAN THE SHOCK BUTTONS ON THE PADDLES, CAUSING THE CHARGE TO BE DROPPED. AT LEAST 6 MINUTES ELAPSED BEFORE THE ECG LEADS WERE REMOVED AT WHICH THE RHYTHM WAS STILL SHOWING VF. IT IS UNK IF ANOTHER DEVICE WAS USED ON THE PT. THE REPORTED EVENT WAS DETERMINED TO BE CAUSED BY USE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DALLAS FIRE DEPARTMENT WAS DISPATCHED TO A CARDIAC ARREST CALL AND AFTER APPROXIMATELY 18 MINUTES OF MONITORING THE PT, THEY CHARGED UP THE DEVICE FOR DEFIBRILLATION AND 2 SECONDS LATER, THE CHARGE WAS REMOVED. THE CREW THEN ATTEMPTED TO CHARGE AGAIN 2 MINUTES LATER WITH THE SAME RESULT, THEN AGAIN ANOTHER 2 MINUTES LATER WITH THE SAME RESULT. THE CREW WAS USING HARD PADDLES ON THE PT DURING THE EVENT. THE CUSTOMER ADVISED THAT AN INTERN WAS AT THE CONTROLS OF THE DEVICE DURING THE EVENT AND VERY WELL COULD HAVE HIT THE ENERGY SELECT BUTTON WHEN THE DEVICE WAS CHARGED, INSTEAD OF THE SHOCK BUTTON, WHICH WOULD REMOVE THE ENERGY. THE PT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death