BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1983610 · Received February 3, 2011

    Report

    Report Number
    3015876-2011-00107
    Event Type
    Death
    Date Received
    February 3, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CLINICAL SPECIALIST REVIEW OF THE REPORTED EVENT DETERMINED THAT USE ERROR MAY HAVE CONTRIBUTED TO THE OUTCOME OF THE PT. THE EVENT RECORD DOWNLOAD SHOWS THAT THE DEVICE POWERED OFF ONE MINUTE AND 42 SECONDS AFTER A 360 JOULE SHOCK WAS DELIVERED TO THE PT. THE DEVICE WAS POWERED BACK ON AND WAS USED TO MONITOR THE PT FOR TWO MINUTES AND 20 SECONDS WHEN A SECOND DEFIBRILLATION SHOCK SHOULD HAVE BEEN DELIVERED. PHYSIO-CONTROL EVALUATED THE DEVICE HOWEVER THE REPORTED FAILURE WAS NOT DUPLICATED. THE CUSTOMER WAS USING ONE THIRD PARTY BATTERY THAT WAS OVER THREE (3) YEARS OLD AND A SECOND PHYSIO BATTERY THAT WAS ALSO OVER THREE (3) YEARS OLD. PHYSIO-CONTROL DOES NOT RECOMMEND USE OF THIRD-PARTY BATTERIES AND RECOMMENDS REPLACING PHYSIO-CONTROL BATTERIES EVERY TWO (2) YEARS. PHYSIO-CONTROL OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE POWERED OFF WHILE CHARGING FOR A DEFIBRILLATION SHOCK. THIS FAILURE OCCURRED DURING A CARDIAC ARREST AND THE PT DID NOT SURVIVE. THERE WAS NO FURTHER INFO ON THE PT OR EVENT PROVIDED.

    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