BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3963097 · Received June 19, 2014

    Report

    Report Number
    1720753-2014-05281
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 19, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE X-RAY TUBE WAS EVALUATED AND REPLACED. A COMPLETE FILAMENT CALIBRATION WAS PERFORMED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A GENERATOR ERROR MESSAGE. THIS WAS RESOLVED BY REBOOTING THE SYSTEM. THIS ERROR MESSAGE WILL LIKELY RESULT IN A SYSTEM LOCKUP AND/OR A NO BOOT SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359572 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1