BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3902421 · Received May 6, 2014

    Report

    Report Number
    1720753-2014-03987
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 6, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE KV CONTROL PCB, GENERIC INTERFACE AND AEC PCB WERE EVALUATED AND REPLACED. THE AEC CALIBRATION FILED WERE ALSO RELOADED AS PART OF THE SERVICE EVENT. 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 AN "GENERATOR ERROR" MESSAGE DISPLAYED. THIS ERROR IS LIKELY TO RESULT IN AN IMMEDIATE LOSS OF SYSTEM FUNCTIONALITY AND AN UN-COMMANDED SHUT DOWN. THERE IS NO REPORT OF A PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272831 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1