BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADV BASIC SYSTEM, UC/MOB, DOM

    MDR report key: 1070627 · Received July 1, 2008

    Report

    Report Number
    1518293-2008-00212
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM FIELDS SERVE REPORT STATES, FIELD SERVICE ENGINEER FOUND THAT THE POWER-HEAD KEYPAD NEED TO BE REPLACED. HE WAS UNABLE TO DUPLICATE INJECTOR RAM GOING BACKWARDS. PERFORMED PM CHECK LIST 800961-D AND VERIFIED OPERATION.

    Description of Event or Problem · 1

    ON EVENT DATE: CUSTOMER REPORTS THAT THE BUTTONS ON THE POWER-HEAD DON'T ALWAYS OPERATE CORRECTLY. THEY WILL HAVE TO PRESS THE BUTTONS REALLY HARD TO MOVE THE RAM, WHEN THEY PUSH THE BUTTON TO RETRACT THE RAM, IT WILL SOMETIME ADVANCE INSTEAD OF RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADV BASIC SYSTEM, UC/MOB, DOM CT POWER INJECTOR SYSTEM DXT LIEBEL-FLARSHEIM CO. CT9000ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK