BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20E DEFIBRILLATOR/MONITOR

    MDR report key: 1112534 · Received August 11, 2008

    Report

    Report Number
    3015876-2008-00915
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 19, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED PROBLEM. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO A FAILURE OF THE POWER SUPPLY ASSEMBLY. AFTER REPLACING THE POWER SUPPLY ASSEMBLY, PROPER OPERATION WAS CONFIRMED, AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DOES NOT DISPLAY THE AC MAINS LIGHT WHEN CONNECTED TO AC MAINS POWER. THE REPORTED PROBLEM IS INDICATIVE OF A FAILURE THAT WOULD RESULT IN THE DEVICE OPERATING ON BATTERY POWER ONLY. THERE WAS NO PATIENT 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