BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOMAT ILLUMENA

    MDR report key: 1082730 · Received July 23, 2008

    Report

    Report Number
    1518293-2008-00231
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER VERIFIED COMPLAINT AND REPLACED THE POWERHEAD HINGE PIN. FSE THEN TESTED INJECTOR FUNCTION AND ALL AVAILABLE FACEPLATES TO ENSURE THE INJECTION PROCESS AND THAT SYSTEM CORRECTLY SEES DIFFERENT FACEPLATES. THIS IS A KNOWN ISSUE ADDRESSED BY CAPA.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT DURING LOADING / UNLOADING PROCESS, THE HINGE PIN BROKE AND FACEPLATE DETACHED FROM THE POWERHEAD. POTENTIAL INJURY EXIST WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOMAT ILLUMENA POWER INJECTOR SYSTEM DXT LIEBEL-FLARSHEIM CO. ILLUMENA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK