BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOMAT CT9000 ADV INJECTOR

    MDR report key: 5310121 · Received September 7, 2004

    Report

    Report Number
    1518293-2004-00015
    Event Type
    Other
    Date Received
    September 7, 2004
    Date of Event
    August 16, 2004
    Report Date
    August 17, 2004
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPENSION ARM, P/N 241047, IS DISTRIBUTED BY (B)(4) AND IS USED IN CONJUNCTION WITH THE MALLINCKRODT L-F CT9000 INJECTOR. FIELD SERVICE ENGINEER REPLACED THE ARM AND BRACKET ASSEMBLY. FSE VERIFIED OPERATION AND RETURNED DEFECTIVE ARM TO L-F TO FORWARD ON TO (B)(4) FOR A QUALITY INVESTIGATION.

    Description of Event or Problem · 1

    SUSPENSION ARM FELL FROM OVERHEAD AND HIT THE TECH IN THE HEAD AND THIGH CAUSING MINOR INJURY. TECH SUFFERED A MINOR CONCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOMAT CT9000 ADV INJECTOR ANGIOGRAPHIC INJECTOR AND SYRINGE DXT LIEBEL-FLARSHEIM CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other