BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 6800

    MDR report key: 1001341 · Received February 22, 2008

    Report

    Report Number
    1720753-2008-16350
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 21, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND REPLACED THE CAMERA. SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SYS PRODUCE EXPOSURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 6800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1