BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 706835 · Received April 28, 2006

    Report

    Report Number
    3015876-2006-00129
    Event Type
    Malfunction
    Date Received
    April 28, 2006
    Date of Event
    March 29, 2006
    Report Date
    March 29, 2006
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS
    Product Code
    LDD
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    OUT OF BOX FAILURE. MEDTRONIC ERS FIELD CLINICAL SPEC. REPORTS THAT DURING HOS. IN-SERVICING THE DEVICE WOULD INTERMITTENTLY NOT COMPLETE THE POWER ON SEQUENCE AND WOULD REMAIN AT A WHITE SCREEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA