BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA SYNERGY

    MDR report key: 6645986 · Received June 16, 2017

    Report

    Report Number
    9617016-2017-00015
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Date of Event
    May 22, 2017
    Report Date
    July 12, 2017
    Manufacturer
    ELEKTA LTD
    Product Code
    IYE
    PMA / PMN Number
    K05193
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE RESULTS DEMONSTRATE THE POTENTIAL FOR INCORRECT CHARACTERIZATION OF COUCH VALUES, WHICH WOULD LEAD TO INCORRECT TABLE MOVEMENT WHEN USING COUCH MOVE ASSISTANT (CMA) FEATURE IN MOSAIQ . THIS IS A RESULT OF THE MACHINE CHARACTERIZATION (MAC) FILE, WHICH IS INSTRUMENTAL TO THE CORRECT OPERATION OF MOSAIQ AND THE ELEKTA LINAC, BEING INPUT INCORRECTLY. AN IMPORTANT FIELD SAFETY NOTICE (371-01-MSQ-011) HAS BEEN RELEASED FROM THE 30-JUN-2017, TO ALL CUSTOMERS. THIS CONTAINS INSTRUCTIONS FOR A VERIFICATION TESTS CUSTOMERS MUST PREFORM TO ENSURE THE MAC FILE IS CORRECTLY INSTALLED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S PRELIMINARY INVESTIGATION HAS CONFIRMED THAT THE INVERSION OCCURRED DURING THE USE OF CMA AND IN THE VERTICAL AXIS ONLY. A REVIEW OF THE MOSAIQ CONFIGURATION HAS IDENTIFIED THE TABLE WAS NOT CORRECTLY CONFIGURED. ON THE 26TH MAY 2017 THE CHARACTERISATION OF THE SYSTEM HAS SINCE BEEN UPDATED BY ELEKTA. THE TABLE MOVES HAVE BEEN FULLY TESTED AND THE MACHINE RETURNED TO CLINICAL STATE FOLLOWING THE UPDATES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TABLE SHIFT IN THE VERTICAL DIRECTION WAS INVERTED (MOVED THE OPPOSITE DIRECTION TO THAT EXPECTED)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429561 ELEKTA SYNERGY ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LTD

    Patients

    Seq Age Sex Outcome Treatment
    1