BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3970799 · Received April 29, 2014

    Report

    Report Number
    1720753-2014-03755
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 29, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR WAS EVALUATED AND A BROKEN WIRE WAS REPAIRED. THE FSE CALIBRATED THE IRIS STOPS VIA RUS ADN SAVED THE NEW CONFIGURATION FILES TO THE SYSTEM. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM EXHIBITED 'COLLIMATOR IRIS TOO LARGE ERRORS' DURING A PT PROCEDURE. THIS EVENT MAY HAVE RESULTED IN AN ARO (ACCIDENTAL RADIATION OCCURRENCE). NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255803 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1