BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA SYNERGY

    MDR report key: 18747006 · Received February 21, 2024

    Report

    Report Number
    9617016-2024-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Report Date
    July 15, 2024
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    PMA / PMN Number
    K051932
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 0

    H6 UPDATED. H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED THAT THE MACHINE BEAM WAS OUT OF TOLERANCE AND STOPPED CLINICAL OPERATIONS. THE INVESTIGATION FOUND THAT THIS ISSUE IS SITE SPECIFIC. THE SYMMETRY/FLATNESS AND PERCENTAGE DEPTH DOSE (PDD) HAD NOT BEEN CHECKED FOR 3 YEARS BY THE CUSTOMER BECAUSE THE WATER PHANTOM EQUIPMENT HAD NOT BEEN WORKING FOR 2.5 YEARS. THE WATER PHANTOM EQUIPMENT WAS FIXED AND THIS IS WHEN THE CUSTOMER REALISED THAT THE MACHINE BEAM WAS OUT OF TOLERANCE. QUALITY ASSURANCE (QA) IS IMPORTANT TO ENSURE THAT THE MACHINE IS WORKING WITHIN SPECIFICATIONS. HAZARDOUS SITUATIONS CAN BE DETECTED AND AVOIDED IF QA IS FOLLOWED PROPERLY. ALL INFORMATION AND WARNINGS ARE LISTED IN THE 1523116_05 ELEKTA MEDICAL LINEAR ACCELERATOR INSTRUCTIONS FOR USE - CLINICAL MODE. THE MACHINE BEAM BEING OUT OF TOLERANCE WOULD HAVE BEEN DETECTED IF MACHINE BEAM QA WAS BEING PERFORMED. THE BEAM PROFILE AND PDD WERE FIXED BY ADJUSTING THE MACHINE PARAMETERS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE MACHINE BEAM IS OUT OF TOLERANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58582 ELEKTA SYNERGY ACCELERATOR, LINEAR, MEDICAL IYE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown