BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX LEGACY CLASSICAL RADIOGRAPHY AND FLUOROSCOPY S

    MDR report key: 490393 · Received October 22, 2003

    Report

    Report Number
    490393
    Event Type
    Malfunction
    Date Received
    October 22, 2003
    Date of Event
    August 1, 2003
    Report Date
    August 1, 2003
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WAS ON A FLUORO TABLE FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE FLUORO MACHINE/TUBE WARMED UP AS PER PROCEDURE. AFTER THE PT WAS SEDATED, FLUORO WAS PULLED INTO PLACE AND MALFUNCTIONED. IMAGES WERE UNABLE TO BE SEEN. BIOMEDICAL SERVICES WERE CALLED TO REPAIR THE MACHINE. THE PT WAS MOVED TO RECOVERY AND THE PROCEDURE WAS DONE LATER THAT AFTERNOON. GE MEDICAL SYSTEMS FOUND A BAD POWER SUPPLY, WHICH WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTX LEGACY CLASSICAL RADIOGRAPHY AND FLUOROSCOPY S RADIOGRAPHY AND FLUOROSCOPY JAA GENERAL ELECTRIC MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other