BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1192683 · Received October 8, 2008

    Report

    Report Number
    3015876-2008-01466
    Event Type
    Death
    Date Received
    October 8, 2008
    Date of Event
    June 6, 2008
    Report Date
    September 16, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL HAS DETERMINED THAT ROOT CAUSE FOR THE REPORTED EVENT IN USE ERROR IN THAT BATTERY READINESS AND MAINTENANCE PROCEDURES WERE NOT FOLLOWED. INFO REGARDING BATTERY READINESS AND MAINTENANCE WAS REVIEWED WITH THE CUSTOMER BY PHYSIO-CONTROL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT: WHILE TREATING A PT IN CARDIAC ARREST, THE DEFIBRILLATOR PROMPTED REPLACE BATTERY. IMMEDIATELY, I WALKED TO THE AMBULANCE 50 METERS AWAY. AT THE SAME MOMENT, THE PT HAD VF AND MY COLLEAGUE STARTED CHARGING THE DEFIBRILLATOR, AND THE DEVICE SHUT OFF BECAUSE OF THE EMPTY BATTERY. THE DEVICE SHUT OFF AFTER ONE (1) REPLACE BATTERY MESSAGE. IT WASN'T POSSIBLE TO DEFIBRILLATE THE PT AT THE TIME HE HAD VF, AFTER RETURNING WITH OTHER BATTERIES, THE PT HAD A ESCAPE RHYTHM. 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. LIFEPAK 12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death