BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2971774 · Received February 6, 2013

    Report

    Report Number
    1720753-2013-01501
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 6, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SNUBBER BOARD WAS REPLACED DURING THE SERVICE CALL. THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DOES NOT EMIT X-RAYS. THE RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51672 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1