BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1053403 · Received May 28, 2008

    Report

    Report Number
    3015876-2008-00534
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 30, 2008
    Report Date
    April 30, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 ASSEMBLY 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 ASSEMBLY AND DETERMINED THAT ROOT CAUSE FOR THE REPORTED INCIDENT WAS AN ELECTRICALLY LEAKY FILTER, DESIGNATOR FL4, DUE TO SOLDER FLUX RESIDUE ON THE PCB.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE WON'T FUNCTION ON BATTERY POWER, WORKS OK ON AC POWER. THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA