BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 6800 MINIVIEW

    MDR report key: 901403 · Received August 22, 2007

    Report

    Report Number
    1720753-2007-04583
    Event Type
    Malfunction
    Date Received
    August 22, 2007
    Date of Event
    August 2, 2007
    Report Date
    August 22, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE OEC SERVICE REP INVESTIGATED THE ISSUE AND RE-SEATED THE CONTROLLER PCB AND THE UNIVERSAL NODE OCB TO RESTORE FUNCTION. 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 OEC 6800 FLUOROSCOPY SYSTEM WOULD NOT FLUORO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR