BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3882189 · Received June 18, 2014

    Report

    Report Number
    3015876-2014-00674
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A BROKEN INTERNAL STRAP FROM THE CAPACITOR FOIL WITHIN THE MAIN HIGH ENERGY CAPACITOR. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS SHOWING ITS SERVICE WRENCH AND NEEDED ATTENTION. UPON EVALUATION BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE WOULD NOT DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358658 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1