BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK (R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 928647 · Received October 16, 2005

    Report

    Report Number
    3015876-2007-00417
    Event Type
    Death
    Date Received
    October 16, 2005
    Report Date
    September 20, 2007
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K983393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL, INC. EVALUATED THE DEVICE. THE ROOT CAUSE COULD NOT BE DETERMINED. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED TO ATTEMPT TO RESUSCITATE A FEMALE, HOSPICE PATIENT DUE TO NO DNR AVAILABLE. THE LP 5000 GAVE A CONNECT ELECTRODES ALARM WHEN USED WITH TWO DIFFERENT SETS OF ELECTRODES. A DIFFERENT DEVICE WAS NOT AVAILABLE FOR USE. THE PATIENT EXPIRED. ACCORDING TO THE VOLUNTEER FIRE DEPT, THE PATIENT WAS DOWN APPROXIMATELY 8 MINUTES PRIOR TO ATTEMPTS TO RESUSCITATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death