BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9900

    MDR report key: 1915525 · Received February 12, 2009

    Report

    Report Number
    1720753-2009-01317
    Event Type
    Malfunction
    Date Received
    February 12, 2009
    Date of Event
    February 3, 2009
    Report Date
    February 11, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SOFTWARE UPGRADE WAS INSTALLED DURING THE SERVICE 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 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9900 SYSTEM LOCKED UP DURING A CASE. THE 9900 SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. 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