BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9900

    MDR report key: 1140909 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24336
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 18, 2008
    Report Date
    August 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM, AND VERIFIED REPORTED IN ONE IMAGE TAKEN BY CUSTOMER, BUT WAS UNABLE TO REPRODUCE THE REPORTED PROBLEMS AND COULD FIND NOTHING WRONG WITH SYSTEM. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POOR IMAGE QUALITY AND AN ARTIFACT IN THE IMAGE. NO PATIENT 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