BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1140680 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24302
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 5, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP COULD NOT REPRODUCE THE PROBLEM. HE RELOADED THE SOFTWARE AND RESTORED THE RUS FILES. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM LOCKED UP AND HAD TO BE REBOOTED. NO PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1