BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3950889 · Received June 13, 2014

    Report

    Report Number
    1720753-2014-05083
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 13, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR WAS CALIBRATED 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 A COLLIMATOR IRIS POT ERROR. THIS ERROR DISABLES X-RAY FUNCTIONALITY ON THIS SYSTEM. THIS COULD RESULT IN THE DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350768 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1