BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOMAT ILLUMENA

    MDR report key: 1062299 · Received June 18, 2008

    Report

    Report Number
    1518293-2008-00209
    Event Type
    Malfunction
    Date Received
    June 18, 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
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING INVESTIGATION PENDING, WHEN INVESTIGATION IS COMPLETED A SUPPLEMENTAL MED WATCH 3500A REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REGIONAL SERVICE REPORTS THAT THE CUSTOMER STATED THE HINGE PIN WAS BROKE AND WHEN THEY OPENED THE FACEPLATE, IT CAME OFF IN THEIR HANDS. THERE WAS NO PATIENT PROCEDURE BEING PERFORMED.

    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