BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 14654359 · Received June 10, 2022

    Report

    Report Number
    3015232217-2022-00004
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 11, 2022
    Report Date
    July 19, 2022
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002336
    PMA / PMN Number
    K183034
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED A TREATMENT WITH HEXAPOD (THIRD PARTY PRODUCT) POTENTIALLY IN THE WRONG POSITION WHILST USING THIS WITH MOSAIQ. HEXAPOD IS USED FOR THE PRECISE POSITIONING OF THE PATIENT ON THE TABLE FOR TREATMENT. HEXAPOD TRANSMITS TABLE CORRECTION DATA TO MOSAIQ FOR SHIFTS TO BE APPLIED USING CMA (COUCH MOVE ASSIST). WHEN A PATIENT OR TREATMENT IS SELECTED IN MOSAIQ, THE DATA IS TRANSMITTED TO THE WEB INTERFACE MAKING IT AVAILABLE FOR THIRD PARTY PATIENT POSITIONING SYSTEMS TO USE. MOSAIQ WILL ONLY VERIFY THE DATA WHEN A SHIFT IS RECEIVED FROM THE THIRD PARTY PRODUCT. THE INVESTIGATION FOUND THAT A SYSTEM CRASH FORCED A RESET OF MOSAIQ BUT NOT ON IGUIDE (3RD PARTY PRODUCT) WHERE THE PATIENT REMAINED SELECTED WITH THE WORKFLOW STILL SHOWING IN PROGRESS. WHEN MOSAIQ WAS RESTARTED AND THE USER SELECTED ANOTHER PATIENT, MOSAIQ BROADCAST THE CHANGE OF PATIENT INFORMATION AND THIS WAS AVAILABLE FOR IGUIDE TO CONSUME. THE ISSUE WAS A CONSEQUENCE OF THE DISCONNECT BETWEEN SYSTEMS THAT RESULTED FROM THE MOSAIQ CRASH AND THE POINT THAT IGUIDE WAS IN AFTER THAT OCCURRED. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND IS WORKING AS DESIGNED AND INTENDED. BASED ON THE AVAILABLE INFORMATION, THERE WAS NO PATIENT MISTREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED MOSAIQ POTENTIAL TREATMENT WITH HEXAPOD IN THE WRONG POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195111 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB MOSAIQ 00858164002336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown