BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3882758 · Received April 10, 2014

    Report

    Report Number
    1720753-2014-03134
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 10, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. A COMPLETE FILAMENT 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 X-RAY DISABLED ERROR MESSAGE. THIS RESULTED IN AN INTERMITTENT, RECOVERABLE 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
    216489 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1