BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA MEDICAL LINEAR ACCELERATOR

    MDR report key: 15130722 · Received July 29, 2022

    Report

    Report Number
    3015232217-2022-00010
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Report Date
    February 28, 2023
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    PMA / PMN Number
    K210500
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    H2 UPDATED. H6 UPDATED. H10 UPDATED: THE PRODUCT OF CONCERN, INTERLOCKED CIRCULAR SMALL FIELD COLLIMATORS, IS ONE THAT IS SOLD TO ELEKTA CUSTOMERS ALONGSIDE THE ELEKTA PRODUCT RANGE. ELEKTA HAS BEEN PURSUING THIS ISSUE WITH THE LEGAL MANUFACTURER AKTINA MEDICAL CORPORATION. AKTINA MEDICAL CORPORATION HAS A PLAN OF ACTION TO RE-CHECK DEMONSTRATION OF COMPLIANCE TO IEC 60601 BETWEEN THE OLD AND NEW PRODUCTION METHODS. IT WILL BE UP TO AKTINA MEDICAL CORPORATION TO PURSUE ANY FIELD ACTIONS THAT ARE DEEMED APPROPRIATE. IF THERE ARE NO AFFECTED PRODUCT IDENTIFIED IN THE UNITED STATES, FDA WILL NOT HEAR ANY FURTHER ON THIS ISSUE FROM ELEKTA OR AKTINA MEDICAL CORPORATION.

    Description of Event or Problem · 0

    AKTINA A 3RD PARTY SUPPLIER OF CONES, HAVE CHANGED THEIR DENSITY RELEASE INSPECTION METHOD FOR DETECTING BEAM CONE VOIDS. THE CONES ARE INTEGRATED INTO ELEKTA MEDICAL LINEAR ACCELERATOR WHERE THE PLANNED RADIATION DOSE IS DIRECTED THROUGH THE CONE. THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2281436 ELEKTA MEDICAL LINEAR ACCELERATOR ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB 152344

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown