BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 677376 · Received February 15, 2006

    Report

    Report Number
    3015876-2006-00042
    Event Type
    Malfunction
    Date Received
    February 15, 2006
    Date of Event
    January 19, 2006
    Report Date
    January 20, 2006
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    OUT-OF-BOX FAILURE OBF. WHEN THE DEVICE WAS RECEIVED BY THE CUSTOMER, ALL THE ICONS WERE DISPLAYED. WHEN THE DEVICE WAS POWERED ON, IT SHUT DOWN A FEW SECONDS LATER AND WOULDN'T STAY POWERED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR PLUS DEFIBRILLATOR EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR MKJ MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA