BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4024134 · Received August 4, 2014

    Report

    Report Number
    1720753-2014-06659
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 4, 2014
    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 SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE MA NULL VALVES WERE ADJUSTED AND A FULL FILAMENT CALIBRATION WAS PERFORMED. THE HVSR, GENERATOR INTERFACE PCB ADN FLUOROSCOPY FUNCTIONS PCB WERE ALSO REMOVED AND RESEATED. 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 MA SENSOR FAILURE 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
    455123 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1