BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOMAT ILLUMENA

    MDR report key: 1062289 · Received June 17, 2008

    Report

    Report Number
    1518293-2008-00200
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 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 STATES THAT THE FIELD SERVICE ENGINEER REPLACED BROKEN HINGE PIN, AND PERFORMED OPERATIONAL VERIFICATION IN ACCORDANCE WITH THE SERVICE MANUAL PN 900955-C CHAPTERS 2 + 6. ALL TEST PASSED AND UNIT FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    ON MAY 19: CUSTOMER REPORTS, "AS THEY WERE OPENING THE PRESSURE SLEEVE TO LOAD THE SYRINGE, THE PRESSURE SLEEVE DETACHED FROM THE ILLUMENA POWERHEAD DUE TO BROKEN HINGE PIN. NO INJURIES.

    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