BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOMAT ILLUMENA

    MDR report key: 1210232 · Received October 21, 2008

    Report

    Report Number
    1518293-2008-00318
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Report Date
    September 22, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MANUFACTURING REPORT: FIELD SERVICE ENGINEER NOTED AND REPLACED A BROKEN HINGE PIN. UPON COMPLETION OF REPAIRS, THE SYSTEM WAS TESTED FOR PROPER OPERATION PER THE INJECTOR'S INSTALLATION AND SERVICE MANUAL. THE UNIT WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    LIEBEL FLARSHEIM FIELD SERVICE ENGINEER REPORTS VIA TESS RECORD THAT DURING A SERVICE VISIT FOR OTHER INJECTOR SYSTEM EVENTS, IT WAS NOTED THAT THE PRESSURE PLATE HINGE PIN WAS BROKEN. CUSTOMER HAD NOT REPORTED ANY FAILURE EVENTS WITH REGARDS TO THIS TYPE OF MALFUNCTION. NO PT 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