BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPX GENERATOR

    MDR report key: 45390 · Received October 22, 1996

    Report

    Report Number
    45390
    Event Type
    Malfunction
    Date Received
    October 22, 1996
    Date of Event
    May 16, 1996
    Report Date
    October 22, 1996
    Manufacturer
    GENERAL ELECTRIC COMPANY
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO CO THAT FLUOROSCOPY FAILED ON THE SYSTEM DURING A PTCA PROCEDURE. APPARENTLY IMAGE LOSS HAPPENED AFTER A VESSEL DISSECTION OCCURRED. THE PT UNDERWENT EMERGENCY OPEN HEART SURGERY TO REPAIR THE VESSEL DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPX GENERATOR DIAGNOSTIC X-RAY IZO GENERAL ELECTRIC COMPANY 46-240483G1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR