BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3162137 · Received June 3, 2013

    Report

    Report Number
    1720753-2013-06673
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    March 14, 2013
    Report Date
    June 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE FILAMENT DRIVER WAS IDENTIFIED AS BEING FAULTY. NO FURTHER REPAIR INFORMATION IS AVAILABLE AT THIS TIME. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED THAT THE SYSTEM DISPLAYED A FILAMENT REGULATOR FAILED ERROR MESSAGE DURING A PT PROCEDURE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243896 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1