BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 948984 · Received November 16, 2007

    Report

    Report Number
    3015876-2007-00482
    Event Type
    Death
    Date Received
    November 16, 2007
    Date of Event
    October 11, 2007
    Report Date
    October 11, 2007
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K983393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL, INC. EVALUATED THE DEVICE, BUT WAS UNABLE TO DUPLICATE THE REPORTED CONDITION. THE RETURNED ASSEMBLY WAS TROUBLESHOOT BY PRODUCT PERFORMANCE. THE REPORTED PROBLEM COULD NOT BE DUPLICATED OR CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE GAVE A "CONNECT ELECTRODES" MESSAGE DESPITE BEING CONNECTED TO A PATIENT. THREE PACKAGES OF ELECTRODES WERE USED, NONE OF WHICH THE DEVICE WAS ABLE TO DETECT. THE PATIENT, A FEMALE WAS IN A NURSING HOME WITH RESPIRATORY FAILURE. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death