BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK EXPRESS DEFIBRILLATOR

    MDR report key: 1121963 · Received August 13, 2008

    Report

    Report Number
    3015876-2008-00946
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE.

    Description of Event or Problem · 1

    PHYSIO-CONTROL ENGINEERS ARE INVESTIGATING REPORTS OF DC FAILURE WHEN A LIFEPAK EXPRESS DEVICE WAS DROP TESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA