BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3963142 · Received June 19, 2014

    Report

    Report Number
    1720753-2014-05260
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 19, 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 ON SITE INVESTIGATION. THE FILAMENT DRIVER PCB WAS EVALUATED AND REPLACED. A COMPLETE FILAMENT CALIBRATION WAS PERFORMED. THE POWER CAP MODULE WAS RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A PRECHARGE VOLTAGE ERROR. THIS ERROR WILL LIKELY PREVENT THE SYSTEM FROM BOOTING, WHICH WOULD RESULT IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359368 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1