BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1070360 · Received June 30, 2008

    Report

    Report Number
    3015876-2008-00638
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REPLACED POWER SUPPLY ASSEMBLY AND DETERMINED THAT ROOT CAUSE FOR THE REPORTED FAILURE WAS AN ELECTRICALLY LEAKY FILTER, DESIGNATOR FL14.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE IS TURNED ON, IT WILL DISPLAY A SERVICE INDICATOR. THE DEVICE WILL NOT TURN OFF BY PRESSING THE POWER BUTTON. ALSO, WHEN RUNNING AN USER TEST IT CONTINUOUSLY RESTARTS THE SELF TEST AND DOES NOT COMPLETE IT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    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