BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2935252 · Received January 14, 2013

    Report

    Report Number
    1720753-2013-00626
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE FLUORO FUNCTIONS BOARD, CINE DRIVE, AND THE SOFTWARE UPGRADE WERE INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND OUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM HAD A COMMUNICATION ERROR. THIS ERROR MAY RESULT IN A SYSTEM LOCK UP, NO BOOT, OR SHUT DOWN SITUATION DEPENDING ON WHEN THE LOSS OF COMMUNICATION OCCURRED. THERE IS NOT REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21497 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1