BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1000607 · Received February 21, 2008

    Report

    Report Number
    1720753-2008-16308
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 21, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. BASED ON INFORMATION PROVIDED THE FOLLOWING COMPONENTS HAVE BEEN ORDERED. HARD DRIVE, GENERATOR INFORMATION PCB, IMAGE PROCESSOR PCB. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENTS ARE REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADDITIONAL INFORMATION IS RECEIVED THAT INDICATES OTHERWISE, A FOLLOWUP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER TAKING THREE FLUORO SHOTS WITH THE 9900 SYSTEM THE FORTH SHOT HAD A GREY AND TORN IMAGE AND THE MAINFRAME PRESENTED A COMMUNICATION FAILURE MESSAGE. THE SYSTEM WAS REBOOTED AND THE SAME THING HAPPENED. HOWEVER, THE CASE WAS COMPLETED AND THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK