BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 19729041 · Received July 12, 2024

    Report

    Report Number
    3015232217-2024-00024
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 14, 2024
    Report Date
    September 2, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002336
    PMA / PMN Number
    K183034
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 UPDATED. SECTION H11 UPDATED. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE SHAPED PORT THAT WAS DISPLAYED FOR THE FIRST FIELD WAS THE CIAO (COMPLETELY IRRADIATED AREA OUTLINE) OF THE FIELD. THE FIRST FIELD WAS A STEPNSHOOT TYPE FIELD WHERE COLLIMATION CHANGES DURING A BEAM-ON. BY DESIGN, THE MLC (MULTILEAF COLLIMATOR) CORRECTLY MOVED TO THE CIAO POSITION FOR THE PLANNED PORT EXPOSURE. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND WAS WORKING AS DESIGNED AND INTENDED. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO MISTREATMENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT POSITIONS OF THE BLADES BETWEEN THE MOSAIQ AND MONACO DRRS ARE NOT IDENTICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2380240 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB 00858164002336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown