BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 775545 · Received August 18, 2006

    Report

    Report Number
    3015876-2006-00219
    Event Type
    Malfunction
    Date Received
    August 18, 2006
    Report Date
    July 28, 2006
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUT-OF-BOX FAILURE (OBF). ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS FIRST POWERED ON, THE SERVICE INDICATOR ILLUMINATED AND COULD NOT BE CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR LDD MEDTRONIC EMERGENCY RESPONSE SYSTEMS 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA