BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4214072 · Received October 24, 2014

    Report

    Report Number
    1720753-2014-08886
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE HIGH VOLTAGE CABLE WAS CLEANED AND GREASED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED, FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMAGES PRODUCTED WERE EITHER VERY DARK AND GRAINY WITH HIGH KV AND MA OR PITCH WHITE WITH THE SAME HIGH KV AND MA. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679014 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1