BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3823517 · Received February 19, 2014

    Report

    Report Number
    1720753-2014-01627
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 19, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUES COULD NOT BE DUPLICATED. HOWEVER, THE FE FOUND ERROR IN LOG. A COMPLETE TUBE FILAMENT CALIBRATION WAS PERFORMED. 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 THAT THERE WAS AN INTERMITTENT MA ON IN ERROR MESSAGE. THIS ERROR RESULTS IN A SYSTEM SHUTDOWN. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104237 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 990

    Patients

    Seq Age Sex Outcome Treatment
    1