BEUDAMED
    FDA Adverse Event Summary report: N

    GE CATH LAB X-RAY SYSTEM

    MDR report key: 34887 · Received July 11, 1996

    Report

    Report Number
    34887
    Date Received
    July 11, 1996
    Date of Event
    June 5, 1996
    Report Date
    July 8, 1996
    Manufacturer
    GENERAL ELECTRIC CO.
    Product Code
    IZI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    DURING AN ANGIOPLASTY THE X-RAY IMAGING EQUIPMENT BECAME NON-FUNCTIONAL WITHOUT WARNING; ONLY TRANSIENT FUNCTIONING OF THE EQUIPMENT WAS ACHIEVED. AT THIS TIME INJECTIONS OF THE RIGHT CORONARY WITH 80-85% LESION, NO EVIDENCE OF DISSECTION. RECOVERY OF THE SYSTEM WAS NOT POSSIBLE. PT WAS OBSERVED. ABOUT 40 MINUTES POST INFLATION PT COMPLAINED OF CHEST PAIN. EKG SHOWED NO ABNORMALITY. CHEST PAIN CONTINUED DESPITE IV NITRO. PT TAKEN TO OR FOR BYPASS OF RIGHT CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE CATH LAB X-RAY SYSTEM CATH LAB X-RAY SYSTEM IZI GENERAL ELECTRIC CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR