BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3791765 · Received January 6, 2014

    Report

    Report Number
    1720753-2014-00163
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 18, 2013
    Report Date
    January 6, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE KV CONTROLLER AND AEC PCB ASSEMBLY WERE EVALUATED AND REPLACED AND AN AEC AND GENERATOR FILAMENT CALIBRATION WERE 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 A GENERATOR ERROR MESSAGE. THE SYS SHUTS DOWN WHEN THIS OCCURS, 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
    8649 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1