BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2191666 · Received July 27, 2011

    Report

    Report Number
    1720753-2011-20478
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 27, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE REAL TIME OPERATING SYSTEM BOARD, THE GENERATOR INTERFACE BOARD, THE SYSTEM INTERFACE BOARD, AND THE FLUORO FUNCTIONS BOARD WERE REPLACED. THE SOFTWARE AND CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X- RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1