BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3982754 · Received July 24, 2014

    Report

    Report Number
    1720753-2014-06365
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 25, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM BATTERIES AND HIGH VOLTAGE WERE EVALUATED AND REPLACED. A COMPLETE FILAMENT AND GENERATOR CALIBRATION WAS PERFORMED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVERLOAD FAULT ERROR MESSAGE. THIS ERROR CAUSES THE SYSTEM TO SHUT DOWN. RESULTING IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435132 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1