BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1033489 · Received April 23, 2008

    Report

    Report Number
    3015876-2008-00379
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K890079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL MADE AN OFFER OF SERVICE TO THE CUSTOMER WHICH WAS DECLINED. PHYSIO SUPPLIED PART INFO TO CUSTOMER FOR REPAIR.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHEN ON EITHER AC POWER OR BATTERY POWER, THE DEVICE WON'T POWER ON AND BLOWS MAIN 15 AMP SLOW BLOW FUSE, DESIGNATOR F1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER LDD PHYSIO-CONTROL, INC. 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA