BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3802123 · Received December 30, 2013

    Report

    Report Number
    1720753-2013-13865
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    December 11, 2013
    Report Date
    December 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE SYSTEM WAS EVALUATED AND A FULL FILAMENT CALIBRATION WAS PERFORMED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE. THIS MALFUNCTION MAY BE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM EXHIBITED HIGH MA ERRORS DURING A PATIENT PROCEDURE. THIS EVENT MAY HAVE RESULTED IN AN ARO (ACCIDENTAL RADIATION OCCURRENCE). NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679817 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1