BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 20589280 · Received November 1, 2024

    Report

    Report Number
    3015232217-2024-00031
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    October 3, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002367
    PMA / PMN Number
    K183034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE USER INTENDED TO TREAT THE FIELDS BELONGING TO PRESCRIPTION SITE RECTUM FOR 25 FRACTIONS BEFORE STARTING THE TREATMENT TO PRESCRIPTION SITE PROSTATE FOR 14 FRACTIONS. ACCORDING TO THE SOFTWARE LOGS, THE USER SCHEDULED THE FIELDS FROM BOTH PRESCRIPTION SITES IN THE SAME TREATMENT CALENDAR SESSIONS TO BE GIVEN CONCURRENTLY. THE FIELDS FROM BOTH PRESCRIPTION SITES WERE TREATED CONCURRENTLY FOR THE FIRST 14 FRACTIONS THEREBY COMPLETING THE PROSTATE PRESCRIPTION WHILE LEAVING 11 MORE FRACTIONS FOR THE RECTUM PRESCRIPTION. ANOTHER 4 FRACTIONS WERE GIVEN AND AT THIS POINT, IT APPEARED THAT THE CUSTOMER MAY HAVE REALISED THEIR CONCURRENT OPERATION ERROR BECAUSE NO FURTHER TREATMENTS WERE ADMINISTERED. BASED UPON AVAILABLE INFORMATION ELEKTA PHYSICS HAVE ASSESSED THIS AS A SERIOUS RADIATION OVERDOSE. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND WAS WORKING AS DESIGNED AND INTENDED. THIS ISSUE WAS DUE TO USE ERROR. THE USER INCORRECTLY SET UP THE TREATMENT CALENDAR TO DELIVER BOTH PRESCRIPTION SITES CONCURRENTLY RATHER THAN SEQUENTIALLY. H4: MANUFACTURING DATE IS NOT ON THE LABEL, BUT IT IS KNOWN SO FIELD H4 HAS BEEN COMPLETED WITH THIS INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY HAD AN IRRADIATION INCIDENT ON A PATIENT DUE TO A MISSING VOLUME INFORMATION IN THE AVAILABLE FIELD AS THERE WAS LACK OF SPACE FOR WRITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2176331 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB VERSION 2.84.002 00858164002367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown