BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR, OPTIVANTAGE DH

    MDR report key: 983708 · Received January 22, 2008

    Report

    Report Number
    1518293-2008-00005
    Event Type
    Malfunction
    Date Received
    January 22, 2008
    Date of Event
    December 26, 2007
    Report Date
    December 26, 2007
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM FIELD SERVICE REPORT: FSE REPORTS THAT THE J-BOW SUSPENSION WAS ORIGINAL REV. A J-BOW. SUSPENSION HAD SPUN 360 DEGREES AND SHEARED OFF SUPPORT SCREWS. REPLACED J-BOW AND SUSPENSION ARM WITH UPGRADED J-BOW. INJECTOR SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    LFI OPTV SUSPENSION FAILURE-J-BOW/FELL FROM CEILING. CUSTOMER REPORTS, "TECHNOLOGIST WAS MOVING INJECTOR INTO A POSITION TO SET UP FOR THE NEXT PT WHEN THE J-BOW FAILURE OCCURRED. THE INJECTOR FELL TO THE FLOOR, WITH NO INJURIES REPORTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTOR, OPTIVANTAGE DH CT POWER INJECTOR SYSTEM IZQ LIEBEL-FLARSHEIM CO. OPTIVANTAGE DG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other