BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR / MONITOR

    MDR report key: 779159 · Received August 30, 2006

    Report

    Report Number
    3015876-2006-00234
    Event Type
    Malfunction
    Date Received
    August 30, 2006
    Report Date
    August 2, 2006
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUT-OF BOX FAILURE (OBF). WHILE TRAINING HOSPITAL PERSONNEL FOR USE OF THE DEVICE IN AED MODE AND WITH THE DEVICE CONNECTED TO A PATIENT SIMULATOR, THE REPORTER STATED THE DEVICE GAVE A CONTINUOUS "MOTION" ALARM WHEN THE ANALYZE BUTTON WAS PRESSED.

    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