BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2062081 · Received April 6, 2011

    Report

    Report Number
    1720753-2011-03309
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE UNCOMMANDED X-RAYS PROBLEM. THE GE REP CALIBRATED THE GENERATOR TO IMPROVE THE OPTICAL DENSITY AND IMAGE QUALITY. THE SYSTEM OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM CONTINUED TO FLUORO AFTER RELEASING THE PUSH BUTTON AND DISPLAYED AN ERROR MESSAGE. THE CUSTOMER ALSO REPORTED THAT THE OPTICAL DENSITY ON FILM SHOTS WAS LOW. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1