BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3113051 · Received May 9, 2013

    Report

    Report Number
    1720753-2013-05878
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 9, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED. THE SNUBBER BOARD, GENERATOR DRIVE BOARD, AND THE HIGH VOLTAGE REGULATOR WERE REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO 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 THE SYSTEM HAD AN X-RAYS DISABLED ERROR AND AN INTERMITTENT REGULATOR FAILURE DURING A PROCEDURE WITH PT INVOLVEMENT, THEREFORE THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ARO. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204960 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1