BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1001171 · Received February 22, 2008

    Report

    Report Number
    1720753-2008-16380
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 22, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED FAILURES COULD NOT BE DUPLICATED. RELOADED ALL SOFTWARE AND CAL FILES. THE SYSTEM TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FLUORO WITH THE 9900 SYSTEM THE SCREEN WENT BLANK. IT WAS ALSO NOTED THAT WHEN THE FOOT PEDAL WAS RELEASED THE SYSTEM KEPT FLUOROING AND WHEN TRANSFERRING IMAGES TO PACS THEY WERE UNABLE TO LOCATE IMAGES THAT WERE JUST RUN. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI