BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT9000 ADV DOMESTIC BASIC SYS

    MDR report key: 1278977 · Received January 7, 2009

    Report

    Report Number
    1518293-2008-00063
    Event Type
    Malfunction
    Date Received
    January 7, 2009
    Date of Event
    December 18, 2003
    Report Date
    January 8, 2004
    Manufacturer
    LIEBEL - FLARSHEIM CO.
    Product Code
    DXT
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FLARSHEIM FIELD SERVICE REPORT: SERVICE MANAGER REPORTS THAT ARM WAS OLD STYLE SUPPORT ARM AND WAS REPLACED BY L F TECHNICIAN. HE ALSO STATES THE PROBLEM WAS RELATED TO LOOSE SET SCREWS AND WAS ATTRIBUTED TO ABUSE AND LACK OF MAINTENANCE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS SUSPENSION ARM FELL APART, AND WAS CAUGHT BY TECHNICIAN. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT9000 ADV DOMESTIC BASIC SYS CT POWER INJECTOR SYSTEM DXT LIEBEL - FLARSHEIM CO. CT9000ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1