BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3033112 · Received April 1, 2013

    Report

    Report Number
    1720753-2013-04450
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 1, 2013
    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 REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. A FILAMENT CALIBRATION WAS PERFORMED. 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 ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132236 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1