BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2771816 · Received October 2, 2012

    Report

    Report Number
    1720753-2012-07853
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 2, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS CLEANED AND REGREASED. THE LEMO PIN CONNECTOR WAS 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 THAT THERE WAS A FILAMENT REGULATOR ERROR DURING A CASE. THERE WAS NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1