BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3832686 · Received March 27, 2014

    Report

    Report Number
    1720753-2014-02702
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 27, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE TANK AND THE SNUBBER BOARD WERE REPLACED AND THE FILAMENT WAS CALIBRATED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A HIGH MA ERROR MESSAGE DURING A PROCEDURE WITH PATIENT INVOLVEMENT, THEREFORE THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ARO (ACCIDENTAL RADIATION OCCURRENCE). THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179459 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1