BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 16371175 · Received February 14, 2023

    Report

    Report Number
    3015232217-2023-00005
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    January 17, 2023
    Report Date
    May 14, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002367
    PMA / PMN Number
    K183034
    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

    SECTION H4 DEVICE MANUFACTURER DATE ADDED SECTION H6 UPDATED CODING SECTION H11 UPDATED THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE RELATED INFORMATION. THE CUSTOMER SELECTED A PATIENT FOR TREATMENT, BUT THE GLOBAL PATIENT'S NAME AND ID DID NOT UPDATE IN THE UPPER RIGHT CORNER OF THE SCREEN AFTER BEING SELECTED IN MOSAIQ. THE PREVIOUS PATIENT CONTINUED TO BE DISPLAYED IN THE GLOBAL PATIENT'S NAME AND ID, SO THE CUSTOMER RESTARTED MOSAIQ. FOLLOWING THE RESTART, THE CORRECT PATIENT WAS SELECTED AGAIN, AND THE GLOBAL PATIENT INFORMATION UPDATED AS EXPECTED. THE LOGS SHOW THAT THE CORRECT FIELD WAS TREATED AS PRESCRIBED TO THIS PATIENT. THERE WAS NO PATIENT MISTREATMENT. THE ISSUE WAS DETERMINED TO BE A DEFECT WITHIN MOSAIQ, HOWEVER THE DEFECT WAS DETERMINED NOT TO BE A RISK. THE DEFECT OCCURS WHEN THE USER OPENS THE PATIENT CHART FROM A SCHEDULING WINDOW WHICH HELPS THE USER TO SELECT THE INTENDED CHART. THE USER WILL NEED TO LEFT CLICK ON THE MOUSE TO HIGHLIGHT THE CORRECT APPOINTMENT AND THEN RIGHT CLICK THE MOUSE TO OPEN THE CORRECT PATIENT CHART. IF THIS ACTION IS DONE TOO FAST BY THE USER, THE NEW CHART MIGHT NOT OPEN AS EXPECTED BECAUSE THE APPLICATION HAS NOT FINISHED PROCESSING THE HIGHLIGHTED APPOINTMENT BEFORE IT STARTS TO PROCESS THE "OPEN CHART" PROCESS. THE ROOT CAUSE WOULD BE A POTENTIAL DELAY IN THE LEFT MOUSE CLICK PROCESS FINISHING BEFORE THE RIGHT MOUSE CLICK PICKS UP THE ACTUAL HIGHLIGHTED APPOINTMENT. OPENING A CHART FROM A SCHEDULING WINDOW IS NOT CONFIRMATION THAT THE CORRECT PATIENT CHART IS BEING USED. THE PASSIVE AND CONFIGURABLE DISPLAYS IN MOSAIQ CAN BE USED TO VERIFY PATIENT'S IDENTITY: 1. PASSIVE - THE PATIENT'S NAME AND PATIENT ID ARE DISPLAYED AT THE TOP OF THE TREATMENT CHART AND ON EVERY SCREEN THROUGHOUT MOSAIQ. 2. CONFIGURABLE - A PHOTO OF THE PATIENT CAN BE DISPLAYED WHENEVER THE PATIENT'S CHART IS OPENED AS WELL AS IN SITE SETUP VERIFICATION ON THE "SETUP" TAB IN THE PHOTO/DIAGRAM SECTION. - PATIENT VERIFICATION FOR CONVENTIONAL RADIATION TREATMENT CAN BE IMPLEMENTED. - PATIENT VERIFICATION CAN BE IMPLEMENTED USING EXTERNAL SYSTEMS VIA A PATIENT VERIFICATION INTERFACE E.G. FINGERPRINT AND FACIAL RECOGNITION. IN ADDITION, THERE ARE ROUTINE CHECKS DONE BY THE THERAPIST IN THE CLINIC TO VERIFY THE PATIENT'S IDENTITY (OTHER THAN USING BARCODES). 1. ASKING THE PATIENT THEIR NAME 2. ASKING THE PATIENT THEIR DATE OF BIRTH 3. ASKING THE PATIENT WHAT PROCEDURE THEY ARE SCHEDULED FOR 4. VERIFYING THAT ALL THE PATIENT INFORMATION PROVIDED BY THE PATIENT MATCHES THE INFORMATION DISPLAYED IN THE MOSAIQ SCREEN DISPLAYS AND TREATMENT SCHEDULE. THE DISPLAY OF THE WRONG PATIENT CHART WOULD NOT RESULT IN PATIENT HARM AND IS NOT A SAFETY ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A MOSAIQ ID MISMATCH ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810733 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB MOSAIQ 00858164002367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown