BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OFC 9800

    MDR report key: 785900 · Received November 16, 2006

    Report

    Report Number
    1720753-2006-00163
    Event Type
    Malfunction
    Date Received
    November 16, 2006
    Date of Event
    October 18, 2006
    Report Date
    November 16, 2006
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FFB BOARD WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    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 OFC 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *