BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1014284 · Received March 12, 2008

    Report

    Report Number
    1720753-2008-17927
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 11, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPLACED THE POWER INTERFACE BOARD AND POWER SUPPLY. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH MONITORS ON THE 9900 SYSTEM WENT DARK, DISPLAYING NO ERROR MESSAGES, HOWEVER, THE C FULLY BOOT UP DISPLAYING THE TECHNIQUE. IT WAS NOTED THAT THIS HAPPENED DURING SETUP. ANOTHER SYSTEM WAS USED FOR THE PROCEDURE. 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