BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4203054 · Received September 18, 2014

    Report

    Report Number
    1720753-2014-07990
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 18, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE FLUORO FUNCTIONS BOARD WAS REPPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE GENERATOR BOOTED UP TO 17 ARROWS AND THEN DISPLAYED X-RAYS DISABLED MESSAGE. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THIS COULD RESULT IN THE DELAY OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578786 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1