BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2200713 · Received August 4, 2011

    Report

    Report Number
    3015876-2011-00572
    Event Type
    Death
    Date Received
    August 4, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 5, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND THREE BATTERIES THAT WERE IN USE DURING THE EVENT. PHYSIO OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. HOWEVER, THE THREE BATTERIES THAT WERE IN USE DURING THE EVENT WERE COMPLETELY CHARGE DEPLETED. A CLINICAL REVIEW OF THE EVENT DOWNLOAD AND INVESTIGATION RESULTS ATTRIBUTED THE CAUSE OF THE REPORTED INCIDENT TO USE ERROR. THE DEVICE WAS IN USE IN ADVISORY MODE AND LOST POWER SEVEN TIMES DUE TO A LOW BATTERY CONDITION. THERE WAS NO INDICATION THAT THE DEVICE OPERATOR REPLACED THE DEPLETED BATTERIES WITH FULLY CHARGED BATTERIES DURING THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING DELIVERY OF 200J, DEFIBRILLATION SHOCK TO A PT, THE DEVICE SHOWED "LOW BATTERY" AND A SECOND DEFIBRILLATION SHOCK WAS NOT POSSIBLE DUE TO THE DEVICE POWER LOSS. THE PT DOWNTOWN WAS UNK. THE PT WAS NOT REVIVED. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PT PROVIDED. PHYSIO-CONTROL'S CLINICAL REVIEW OF THE REPORTED EVENT DETERMINED THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE PT OUTCOME AS DEFIBRILLATION WAS NEEDED BUT THE DELIVERY WAS DELAYED GREATER THAN 30 SECONDS.

    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 70 YR Death