BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 4152295 · Received October 2, 2014

    Report

    Report Number
    1720753-2014-08373
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 2, 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 REP PERFORMED AN ONSITE INVESTIGATION. THE KV CONTROL BOARD WAS EVALUATED AND REPLACED. A COMPLETE 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 A GENERATOR ERROR DURING FLUORO AND THEY COULD NOT MAKE AN EXPOSURE. THE SYSTEM 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
    614002 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1