BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3882913 · Received April 4, 2014

    Report

    Report Number
    1720753-2014-02960
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 4, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED DURING THE SERVICE CALL. 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 THE SYSTEM DISPLAYED 'HIGH MA ERROR' AND 'KV ON IN ERROR' MESSAGES. THE KV ON IN ERROR MESSAGE CAUSES THE SYSTEM TO SHUT DOWN. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205216 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1