BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE SYSTEM, ILLUMENA, NON-OEM

    MDR report key: 1060753 · Received June 13, 2008

    Report

    Report Number
    1518293-2008-00202
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM FIELD SERVICE STATES THAT THE FIELD SERVICE ENGINEER REPLACED BROKE HINGE PIN, PERFORMED OPERATIONAL VERIFICATION IN ACCORDANCE WITH SERVICE MANUAL 900955-C CHAPTERS 2 AND 6. ALL TESTS PASSED, UNIT IS FULLY FUNCTIONAL AND THE CUSTOMER RETURNED SYSTEM TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THE TECHNICIAN WAS LOADING A NEW SYRINGE INTO THE PRESSURE SLEEVE, THE FACEPLATE HINGE PIN BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASE SYSTEM, ILLUMENA, NON-OEM INJECTOR DXT LIEBEL-FLARSHEIM CO INJECTOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other