BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK EXPRESS(R) DEFIBRILLATOR

    MDR report key: 3051594 · Received April 10, 2013

    Report

    Report Number
    3015876-2013-00291
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. DUE TO DEPLETED INTERNAL HLC BATTERIES, THE DEVICE WILL NOT POWER ON AND WILL NOT DELIVER THERAPY. A CONCLUSIVE CAUSE FOR THE DEPLETION WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAYED ALL THREE (ATTENTION, CHARGE-PAK AND WRENCH) ICONS. THIS IS INDICATIVE OF A DEVICE THAT MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153267 LIFEPAK EXPRESS(R) DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC EXPRESS

    Patients

    Seq Age Sex Outcome Treatment
    1