BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 930101 · Received October 17, 2007

    Report

    Report Number
    3015876-2007-00415
    Event Type
    Malfunction
    Date Received
    October 17, 2007
    Date of Event
    September 15, 2007
    Report Date
    September 18, 2007
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K983393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO DELIVERY ENERGY WHEN USED FOR A PATIENT IN ARREST. THE PATIENT'S OUTCOME IS UNK.

    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 YR