BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 16596643 · Received March 23, 2023

    Report

    Report Number
    3015232217-2023-00008
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    February 22, 2023
    Report Date
    July 5, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002091
    PMA / PMN Number
    K141572
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 RELATED INFORMATION. THE CUSTOMER ATTEMPTED TO OPEN CHART/CAPTURE FOR A PATIENT FROM THE LOCATION SCHEDULE TO DELIVER TREATMENT, BUT THE CHART FOR A DIFFERENT PATIENT WAS OPENED INSTEAD. THE CUSTOMER CORRECTED THE PATIENT SELECTION SO THAT THE CORRECT PATIENT WAS DISPLAYED. THE LOGS SHOW THAT TREATMENT WAS DELIVERED TO THE INTENDED PATIENT SO THERE WAS NO 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.

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP TO THE FINAL REPORT SUBMITTED ON 13 MAY 2024 TO NOTIFY THAT DUE TO AN ADMINISTRATIVE ERROR THIS CASE WAS SUBMITTED UNDER AN INCORRECT MFR REPORT NUMBER (3015232217-2023-00008) WHICH CAPTURED THE WRONG MANUFACTURER INFORMATION. AN INITIAL AND FINAL (COMBINED) REPORT HAS BEEN SUBMITTED UNDER THE CORRECT MFR NUMBER (SEE REPORT 2950347-2023-00008) WITH THE CORRECT MANUFACTURER.

    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 WRONG PATIENT SELECTED FROM SCHEDULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3273 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB MOSAIQ 00858164002091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown