BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY XVI

    MDR report key: 952292 · Received November 19, 2007

    Report

    Report Number
    9617016-2007-00029
    Event Type
    Malfunction
    Date Received
    November 19, 2007
    Date of Event
    September 24, 2007
    Report Date
    November 19, 2007
    Manufacturer
    ELEKTA LTD.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MALFUNCTIONING LATERAL POTENTIOMETER ASSEMBLY WAS REPLACED AND NORMAL OPERATION RESTORED. ELEKTA, INC. HAD INTERNALLY IDENTIFIED THIS SIMILAR PROBLEM AND ISSUED IMPORTANT NOTICE ON SEPTEMBER 19, 2007 AS A FIELD CORRECTION. THIS SITE VISIT OCCURRED JUST DAYS PRIOR TO THE IMPORTANT NOTICE BEING ISSUED TO AFFECTED SITES.

    Description of Event or Problem · 1

    AN ENGINEER WENT TO THE CUSTOMER SITE TO PERFORM XVI GAIN CALIBRATION WITH THE PHYSICS DEPARTMENT. THE XVI PANEL WAS NOT CORRECTLY RECOGNIZING ITS POSITIONS. NO PT MISTREATMENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY XVI ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR