BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 8800

    MDR report key: 1031029 · Received April 17, 2008

    Report

    Report Number
    9617766-2008-01073
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 14, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE BACK PLANE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM WILL NOT BOOT AND IS DISPLAYING AN ERROR MESSAGE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 8800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1