BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2191158 · Received July 25, 2011

    Report

    Report Number
    1720753-2011-20347
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 25, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION AND REPLACED THE HARD DRIVE AND RELOADED THE SOFTWARE. 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 THE SYSTEM DISPLAYED A DATA ERROR MESSAGE DURING BOOT UP AND WAS LOOSING PT INFO. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1