BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1190641 · Received October 3, 2008

    Report

    Report Number
    3015876-2008-01452
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING THE SERVICE LIGHT AND IT WOULD RESTART ITSELF DURING THE SELF TEST. THERE WERE NO REPORTS OF PT USE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA