BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 940009 · Received November 6, 2007

    Report

    Report Number
    3015876-2007-00462
    Event Type
    Death
    Date Received
    November 6, 2007
    Date of Event
    October 8, 2007
    Report Date
    October 9, 2007
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL, INC. EVALUATED THE DEVICE. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO A FAILURE OF THE THERAPY CABLE ASSEMBLY. AFTER REPLACING THE THERAPY CABLE ASSEMBLY, PROPER OPERATION WAS CONFIRMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. FURTHER ANALYSIS OF THE THERAPY CABLE ASSEMBLY WAS PERFORMED, BUT THE FAILURE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE GAVE A "CONNECT CABLE" ALARM WHEN CONNECTED TO A PATIENT IN AN ARREST. A DIFFERENT DEVICE WAS THEN USED WITH THE SAME ELECTRODES FOR THE PATIENT AND ENERGY WAS DELIVERED. THE PATIENT EXPIRED.

    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 YR Death