BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1071364 · Received July 7, 2008

    Report

    Report Number
    3015876-2008-00758
    Event Type
    Death
    Date Received
    July 7, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 10, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SVC REP EVALUATED THE DEVICE. PROPER OPERATION WAS CONFIRMED DURING FUNCTIONAL AND PERFORMANCE TESTING. THE REPORTED PROBLEM WAS NOT DUPLICATED. UPDATED DEVICE SOFTWARE WAS INSTALLED. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER. A CLINICAL REVIEW OF THE REPORTED INFO CONCLUDED THAT THE LIKELY CAUSE OF THE REPORTED EVENT WAS DUE TO USER ERROR. THE RECORDED ECG DATA WAS INDICATIVE OF THE DEFIBRILLATOR PADDLE BEING PLACED ON TOP OF THE ECG ELECTRODE ON THE PT'S RIGHT ANTERIOR/STERNAL AREA.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE THE DEVICE WITH STANDARD PADDLES TO ADMINISTER A DEFIBRILLATOR SHOCK TO A PT DIAGNOSED IN VENTRICULAR FIBRILLATION. THE DEVICE REPORTEDLY FAILED TO DELIVER THE SHOCK TO THE PT. ULTRASOUND GEL WAS MISTAKENLY USED ON THE DEFIBRILLATOR PADDLES INSTEAD OF DEFIBRILLATION GEL. ANOTHER DEFIBRILLATOR WAS MADE AVAILABLE AND USED TO TREAT THE PT. THE PT WAS NOT RESUSCITATED.

    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 UNK Death