BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 2954128 · Received November 16, 2007

    Report

    Report Number
    1720753-2007-08898
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Date of Event
    April 23, 2007
    Report Date
    November 8, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE (B)(4) SERVICE REPRESENTATIVE INVESTIGATED THE ISSUE AND FOUND INCOMPATIBLE SOFTWARE VERSION THAT WAS UPGRADE TO A NEWER VERSION TO ELIMINATE LOCK-UP ISSUE. THE SYSTEM WAS TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PT INFO WITH RESPECT TO THIS ISSUE. NO PT INJURY OR HARM WAS REPORTED AS A RESULT OF THE NOTED MALFUNCTION.

    Description of Event or Problem · 1

    THE GE (B)(4) 9800 FLUOROSCOPY SYSTEM LOCKED UP SEVERAL TIMES DURING A PROCEDURE. SYSTEM REQUIRED A REBOOT TO CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1