BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20E DEFIBRILLATOR/MONITOR

    MDR report key: 1112522 · Received August 11, 2008

    Report

    Report Number
    3015876-2008-00903
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT OPERATE ON AC POWER. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE DUE TO ELECTRICALLY SHORTED FET TRANSISTORS, AND DIODE ON THE POWER SUPPLY MODULE PORTION OF THE POWER SUPPLY ASSEMBLY. PROPER DEVICE OPERATION WAS CONFIRMED AFTER THE POWER SUPPLY ASSEMBLY WAS REPLACED. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER. NOTE: THIS DEVICE IS NOT CURRENTLY MARKETED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE THAT IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT THE AC MAIN LIGHT IS NOT ILLUMINATED WHEN CONNECTED TO MAINS. THE LACK OF AN AC MAIN LIGHT IS INDICATIVE OF A POWER SUPPLY FAILURE WHICH WOULD RESULT IN THE DEVICE FUNCTIONING ON BATTERY POWER ONLY. THERE WAS NO REPORT OF PT USE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA