BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 2800

    MDR report key: 1011771 · Received March 11, 2008

    Report

    Report Number
    1720753-2008-17863
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE CONVERTERS, POTENTIOMETERS, AND DRIVE BELT WERE REPLACED DURING THE SVC CALL. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN LOWERING THE TABLE ON THE 2800 SYS THE TABLE TILTS PT HEAD DOWN. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1