BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20E DEFIBRILLATOR/MONITOR

    MDR report key: 1112521 · Received August 11, 2008

    Report

    Report Number
    3015876-2008-00902
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 ON THE POWER SUPPLY MODULE PORTION OF THE POWER SUPPLY ASSEMBLY. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED THE AC LOSS ALERT WARNING AND THE AC MAINS LIGHT WAS NOT ILLUMINATED. THE REPORTED PROBLEM IS INDICATIVE OF A FAILURE THAT WOULD RESULT IN THE DEVICE OPERATING ON BATTERY POWER ONLY. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED EVENT.

    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