BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 19948786 · Received August 9, 2024

    Report

    Report Number
    3015232217-2024-00025
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 10, 2024
    Report Date
    May 12, 2025
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    07340201500071
    PMA / PMN Number
    K223229
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    THE CUSTOMER REPORTED THAT AN INCORRECT SEQUENCE STARTED FOR TEMPLATE ACQUISITION IN CMM. AN INVESTIGATION WAS ATTEMPTED BY CONDUCTING AN EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. SEVERAL ATTEMPTS WERE MADE TO COLLECT THE LOGS THAT CONTAIN THE DATA REQUIRED TO INVESTIGATE THE REPORTED PROBLEM, BUT IT WAS NOT POSSIBLE TO RETRIEVE THE LOGS REQUIRED FROM THE TIME PERIOD OF THE INCIDENT. THE ISSUE COULD NOT BE REPRODUCED AND IT WAS NOT POSSIBLE TO DETERMINE IF A MALFUNCTION OCCURRED WITH THE PRODUCT. THE CUSTOMER HAS NOT EXPERIENCED THIS ISSUE SINCE. ELEKTA WILL CONTINUE TO MONITOR THE MARKET FOR RE-OCCURRENCES OF THIS ISSUE. IF THIS ISSUE DOES RE-OCCUR THE DATA MAY LEAD TO BEING ABLE TO REPRODUCE THE PROBLEM AND A ROOT CAUSE MAY THEN BE IDENTIFIED. THIS IS NOT A SAFETY ISSUE AS THIS OCCURS BEFORE THE BEAM IS ON AND THE INCORRECT IMAGING WOULD BE EVIDENT TO THE USER (THROUGH FAILURE/CRASHES AND ALSO VISUAL CUES).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AN INCORRECT SEQUENCE STARTED FOR TEMPLATE ACQUISITION IN CMM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662295 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB 07340201500071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown