BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3821219 · Received April 16, 2014

    Report

    Report Number
    1720753-2014-03311
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 16, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE HV STICKS WERE EVALUATED AND CLEANED. THE GENERATOR BATTERIES WERE EVALUATED AND REPLACED. THE J1 COMPONENT ON TANK WAS FOUND LOOSE. THE J1 COMPONENT WAS TIGHTENED. A COMPLETE FILAMENT CALIBRATION WAS PERFORMED. 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 FILAMENT REGULATOR FAILURE 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
    234095 9900 FLUOROSSOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1