BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9900

    MDR report key: 1152889 · Received September 10, 2008

    Report

    Report Number
    1720753-2008-22210
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 5, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND DETERMINED THE USERS WERE NOT SHUTTING DOWN SYSTEM PROPERLY, PULLING THE POWER CORD INSTEAD OF SHUTTING DOWN SYSTEM WITH POWER SWITCH. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SYSTEM WILL NOT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1