BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2891592 · Received December 7, 2012

    Report

    Report Number
    1720753-2012-10222
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 22, 2012
    Report Date
    December 7, 2012
    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 SUPPLY REGULATOR, FILAMENT DRIVE, AND GENERATOR DRIVER WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A GENERATOR ERROR MESSAGE. THIS ERROR MESSAGE APPEARS WHEN THE SYSTEM DETECTS AN ERROR IN ANY OF THE REGISTERS ASSOCIATED WITH THE HIGH VOLTAGE GENERATOR. THE SYSTEM SHUTS DOWN WHEN THIS OCCURS. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1