BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9900

    MDR report key: 1317451 · Received February 20, 2009

    Report

    Report Number
    1720753-2008-27962
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    October 22, 2008
    Report Date
    November 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE PS3 POWER SUPPLY WAS REPLACED DURING THE SVC CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VERTICAL LIFT COLUMN ON THE 9900 SYSTEM WOULD INTERMITTENTLY NOT WORK. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1