BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1232118 · Received November 4, 2008

    Report

    Report Number
    3015876-2008-01580
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT OPERATE ON BATTERY POWER. PHYSIO REPLACED THE POWER SUPPLY MODULE AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REPLACED POWER SUPPLY MODULE AND DETERMINED THAT ROOT CAUSE FOR THE REPORTED INCIDENT WAS AN ELECTRICALLY LEAKY FILTER, DESIGNATOR FL4, DUE TO SOLDER FLUX RESIDUE ON THE POWER PCB.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE IMMEDIATELY POWERS OFF WHEN AC POWER IS DISCONNECTED TO OPERATE IT ON BATTERY AND THE BATTERY IS NOT BEING CHARGED WHEN IT IS CONNECTED TO AC POWER. THERE WAS NO PATIENT ASSOCIATED WITH THE REPORT.

    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