BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2833310 · Received October 26, 2012

    Report

    Report Number
    1720753-2012-08724
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 26, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE TORX SCREW WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A FILAMENT REGULATOR ERROR MESSAGE DURING A PROCEDURE. THERE IS NO REPORT OF PT INJURY.

    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