BEUDAMED
    FDA Adverse Event Other Summary report: N

    BASE SYSTEM, ILLUMENA, NON-OEM

    MDR report key: 1060934 · Received June 13, 2008

    Report

    Report Number
    1518293-2008-00204
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 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 SERVICE REPORT CONFIRMS USER ERROR RESULTED IN THE INJECTOR BRACKET AND INJECTOR BECOMING DETACHED FROM THE TABLE. FIELD SERVICE ENGINEER REPLACED THE KNOBS AND THE SYSTEM WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    BIO MED CUSTOMER REPORTED THAT THE INJECTOR IS MOUNTED ON A STAND ON THE X-RAY PROCEDURE TABLE, A STAFF MEMBER NOT FAMILIAR WITH THE INJECTOR SET-UP TRY TO REMOVE THE INJECTOR FROM THE BRACKET BUT INSTEAD REMOVED THE BOTTOM PART OF THE BRACKET WHICH FELL ONTO HER TOE, SHE THEN DROPPED THE INJECTOR ONTO THE FLOOR WHICH BROKE THE INJECTOR MANUAL KNOBS. HER SUPERVISOR REPORTED THAT SHE BRUISED ONE OF HER TOES BUT DID NOT BREAK IT. NO PT WAS IN THE ROOM AT THE TIME OF THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other