BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1033487 · Received April 23, 2008

    Report

    Report Number
    3015876-2008-00381
    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
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE 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. FURTHER EVALUATION OF THE REPLACED POWER SUPPLY ASSEMBLY DETERMINED THAT ROOT CAUSE FOR THE REPORTED INCIDENT WAS A LEAKY FILTER, DESIGNATOR FL4.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT OPERATE ON BATTERY. UNIT WORKS FINE WHEN AC IS PLUGGED AT START UP, NOT IF UNIT IS UNPLUGGED FROM AC AND THEN BOOT UP. SCREEN FLASHES AND DEVICE SHUTS DOWN. THERE WAS NO PT ASSOCIATED WITH THE REPORTED INCIDENT.

    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