BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARM + BRACKET ASSY

    MDR report key: 5310155 · Received September 9, 2004

    Report

    Report Number
    1518293-2004-00017
    Event Type
    Other
    Date Received
    September 9, 2004
    Date of Event
    August 6, 2004
    Report Date
    August 13, 2004
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE VISIT WAS DECLINED. RADIOLOGY MANAGER CHECKED OTHER UNITS FOR CORRECT COLLAR ASSEMBLY AND WERE FOUND TO BE OK. PRODUCT ENGINEERS ANSWERED QUESTIONS TO SATISFACTION OF CUSTOMER REGARDING POTENTIAL OF INCORRECT INSTALLATION OF COLLAR. THIS ISSUE WAS RELAYED ON TO SUSPENSION ARM MANUFACTURER, MCMAHON MEDICAL INC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS ACCOUNT HAS A CT9000 ADV INJECTOR WITH A CEILING SUSPENSION SYSTEM INSTALLED BY (B)(6). THE J-BOW ARM DETACHED FROM THE MAIN SUSPENSION ARM ALLOWING THE INJECTOR TO FALL. MINOR INJURY WAS REPORTED TO A TECHNICIAN'S THUMB BUT IS DOING OK NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARM + BRACKET ASSY SUSPENSION ARM DXT LIEBEL-FLARSHEIM CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other