BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3982763 · Received July 24, 2014

    Report

    Report Number
    1720753-2014-06378
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 25, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. AN SBC CPU UPGRADE KIT WAS UTILIZED TO BRING THE SYSTEM FROM VERSION 30 SOFTWARE TO REVISION 8 SOFTWARE. A FILAMENT CALIBRATION WAS ALSO PERFORMED AS PART OF THE SERVICE EVENT. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO BOOT TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435134 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1