BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3172142 · Received June 11, 2013

    Report

    Report Number
    1720753-2013-06975
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 11, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE GENERATOR WAS CALIBRATED DURING THE SERVICE CALL. 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 A FILAMENT REGULATOR FAILURE MESSAGE DURING A PROCEDURE WITH PATIENT INVOLVEMENT, THEREFORE THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ARO. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263442 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1