BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3879777 · Received February 10, 2014

    Report

    Report Number
    1720753-2014-01286
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    January 20, 2014
    Report Date
    February 10, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE TANK, SNUBBER ASSEMBLY, AND SWITCH, EMO SWITCH AND LEMO CONNECTOR WERE EVALUATED AND REPLACED. THE HVSR WAS EVALUATED AND READJUSTED. FILAMENT CALIBRATION WAS PERFORMED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO ALLOW FLUOROSCOPIC EXPOSURES AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87934 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1