BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 8800 FLEXIVIEW

    MDR report key: 1080361 · Received July 24, 2008

    Report

    Report Number
    9617766-2008-00149
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE OEC SERVICE REP INVESTIGATED THE ISSUE AND REMOVED AND REPLACED THE DEFECTIVE PS3 POWER SUPPLY. 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. THIS SYSTEM IS LOCATED IN OTHER COUNTRY.

    Description of Event or Problem · 1

    THE GE OEC 8800 FLUOROSCOPY SYSTEM HAD VERTICAL LIFT COLUMN FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1