BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOMAT CT 9000 ADV INJECTOR

    MDR report key: 5302845 · Received September 15, 2004

    Report

    Report Number
    1518293-2004-00018
    Event Type
    Other
    Date Received
    September 15, 2004
    Date of Event
    August 24, 2004
    Report Date
    August 31, 2004
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CT 9000 ADV INJECTOR WAS EVALUATED BY A FIELD SERVICE ENGINEER AND FOUND TO BE FULLY FUNCTIONAL WITH ALL WARNINGS AND SAFETY FEATURES OPERATING AS INTENDED AND WITHIN MANUFACTURERS SPECIFICATIONS.

    Description of Event or Problem · 1

    AN UNK AMOUNT OF AIR INJECTED INTO PT DURING A CT OF THE CHEST OF A FEMALE PT, APPROXIMATE AGE (B)(6). CUSTOMER REPORTS THEY WERE NOT USING A PREFILLED SYRINGE AND INDICATES THE INCIDENT IS PROBABLY DUE TO POOR TECHNIQUE BY THE TECHNICIAN. PRECAUTIONS WERE TAKEN AS PT WAS TRANSFERRED TO THE CCU FOR THE OBSERVATION. A FOLLOW-UP CT WAS PERFORMED TO VERIFY NO AIR AND PT RELEASED THE FOLLOWING DAY WITH NO ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOMAT CT 9000 ADV INJECTOR ANGIOGRAPHIC INJECTOR AND SYRINGE DXT LIEBEL-FLARSHEIM CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other