BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOMAT CT DIGITAL INJECTION SYSTEM

    MDR report key: 98188 · Received June 11, 1997

    Report

    Report Number
    98188
    Event Type
    Injury
    Date Received
    June 11, 1997
    Date of Event
    May 2, 1997
    Report Date
    May 2, 1997
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE CT OF ABDOMEN, PT COMPLAINING OF CHEST PAIN, SHORTNESS OF BREATH AND WAS COUGHING FOLLOWING THE START OF IV CONTRAST INJECTION. INJECTION OF CONTRAST STOPPED. AIR BUBBLES SEEN IN RIGHT ATRIUM AND RIGHT VENTRICLE. PT SYMPTOMS RESOLVED WITH 100% O2, NITROPASTE AND HYPERBARIC 02 TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOMAT CT DIGITAL INJECTION SYSTEM ANGIOMAT CONTRAST INJECTOR DXT LIEBEL-FLARSHEIM CO. 600024EM3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention