BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 19030573 · Received April 3, 2024

    Report

    Report Number
    3015232217-2024-00012
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    February 14, 2024
    Report Date
    February 21, 2025
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002367
    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

    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 THE MOSAIQ PATIENT PHOTO AT THE BOTTOM OF THE SCREEN DOES NOT CORRESPOND TO THE IDENTITY OF THE SELECTED PATIENT. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCTS AND THE REPORTED INFORMATION. FROM THE AUDIT, MACHINE LOGS, SCREENSHOTS, AND REPORTS, ON 14 FEBRUARY 2024 AT 18:04 FIELD 21 WAS SENT TO THE MACHINE FOR TREATMENT. THE CUSTOMER NOTICED THAT THE PHOTO ID WINDOW DISPLAYED THE PHOTO OF A DIFFERENT PATIENT, YET THE MEDICAL RECORD NUMBER ON THE PHOTO ID WINDOW WAS CORRECT FOR THIS PATIENT. FIELD 21 WAS TREATED AND RECORDED CORRECTLY FOR THIS PATIENT. THE LOGS WERE ALSO CHECKED FOR THE OTHER PATIENT WHOSE PHOTO HAD INCORRECTLY APPEARED. THIS PATIENT HAD BEEN TREATED EARLIER ON THE SAME DAY ON THE SAME MACHINE; AND THE TREATMENTS WERE RECORDED CORRECTLY. BASED UPON THE AVAILABLE INFORMATION THERE WAS NO MISTREATMENT FOR EITHER PATIENT. ELEKTA HAS BEEN UNABLE TO REPLICATE THE ISSUE OR DETERMINE THE ROOT CAUSE OF THE DISPLAY ISSUE. A DIAGNOSTIC UTILITY RECORD (DUR) TO COLLECT DATA WAS PROVIDED TO THE SITE TO FACILITATE THE INVESTIGATION, HOWEVER THE CUSTOMER CONFIRMED ON 30 JANUARY 2025 THAT THE ISSUE HAS NOT REOCCURRED SINCE THE ORIGINAL INCIDENT DATE OF 14 FEBRUARY 2024. IF, HOWEVER THE ISSUE WERE TO RE-OCCUR, THERE IS LIMITED RISK TO THE PATIENT AS STANDARD WORKFLOWS SHOULD VERIFY THE CORRECT PATIENT IS SELECTED FOR TREATMENT. THE CUSTOMER IS ASKED TO CONFIRM THAT THE GLOBAL PATIENT'S NAME AND MEDICAL RECORD NUMBER (MRN) MATCH THE INFORMATION IN THE FLOATING PICTURE ID. IF THERE IS A MISMATCH, THIS IS DETECTABLE PRIOR TO TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE MOSAIQ PATIENT PHOTO AT THE BOTTOM OF THE SCREEN DOES NOT CORRESPOND TO THE IDENTITY OF THE SELECTED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607555 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB 00858164002367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown