BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT9000 ADV DOMESTIC BASIC SYS

    MDR report key: 1279069 · Received January 7, 2009

    Report

    Report Number
    1518293-2008-00100
    Event Type
    Malfunction
    Date Received
    January 7, 2009
    Date of Event
    November 28, 2005
    Report Date
    November 28, 2005
    Manufacturer
    LIEBEL - FLARSHEIM CO.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPORT: LF FIELD SERVICE ENGINEER INVESTIGATION AND REPORTED THE FOLLOWING. THE J-BOW HAD SEPARATED FROM THE SUPPORT ARM.COLLAR SCREW MISSING ALLOWING IT TO DROP DOWN ON J-BOW. WHEN DROP, IT CLEARED RETAINING CLIP TO BACKOUT, ALLOWING J-BOW TO DROP WITH POWERHEAD. LF FSE REPORTS NO DAMAGE TO THE POWERHEAD. FSE RE-ASSEMBLED SUPPORT AND INSERTED NEW SCREW. TIGHTENED SCREWS ON J-BOW AND RETURNED TO FULL SERVICE BY CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE TO LF SERVICE: INJECTOR CAME OFF OF STAND.

    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. CT9000 ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1