BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20E DEFIBRILLATOR/MONITOR

    MDR report key: 1112694 · Received August 11, 2008

    Report

    Report Number
    3015876-2008-00927
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 A FAILURE OF THE POWER SUPPLY ASSEMBLY. PROPER DEVICE OPERATION WAS CONFIRMED AFTER THE POWER SUPPLY ASSEMBLY WAS REPLACED. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    AFTER UNPACKING THE DEVICE AND CONNECTING TO AC MAINS POWER, THE STAFF NOTED THAT THE GREEN MAINS LED WAS NOT ILLUMINATED. THE DEVICE WOULD ONLY SWITCH ON WITH BATTERY POWER. THIS WAS LATER CONFIRMED BY THE BIO-MED DEPARTMENT. THE REPORTED PROBLEM IS INDICATIVE OF A FAILURE THAT WOULD RESULT IN THE DEVICE OPERATING ON BATTERY POWER ONLY.

    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