BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3161681 · Received June 3, 2013

    Report

    Report Number
    1720753-2013-06723
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 4, 2013
    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 SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED OR DUPLICATED. THE SYSTEM WAS OPERATING AS INTENDED. HOWEVER, A FILAMENT CALIBRATION WAS PERFORMED AS A PRECAUTIONARY MEASURE. 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 FAILURE ERROR MESSAGE DURING A PATIENT PROCEDURE. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243830 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1