BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3943651 · Received April 30, 2014

    Report

    Report Number
    1720753-2014-03811
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 30, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE X-RAY TUBE WAS EVALUATED AND RE-CALIBRATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO 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 HIGH MA ERRORS DURING A PATIENT PROCEDURE. THIS EVENT MAY HAVE RESULTED IN AN ARO (ACCIDENTAL RADIATION OCCURRENCE). NO DEATH PATIENT OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258737 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1