BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 20118087 · Received September 2, 2024

    Report

    Report Number
    3015232217-2024-00027
    Event Type
    Malfunction
    Date Received
    September 2, 2024
    Date of Event
    August 2, 2024
    Report Date
    December 12, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    07340201500071
    PMA / PMN Number
    K203172
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6 UPDATED. H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED THAT THE TREATMENT DOSE WAS NOT RECORDED IN MOSAIQ. IT WAS ASCERTAINED FROM THE AUDIT LOGS THAT THE "TREATMENT SESSION IN PROGRESS" WINDOW OPENED AND THE DETAILS OF THE FIELD WERE SELECTED TO VIEW. A SHORT WHILE AFTER THE PLAN WAS SENT, MOSAIQ WAS RESTARTED. THIS IS THE REASON THAT THE "TREATMENT DELIVERY NOT COMPLETE" MESSAGE WAS RECEIVED WHEN COMMUNICATIONS WERE RE-ESTABLISHED AND THE PATIENT'S CHART WAS ACCESSED AGAIN. AT THIS TIME A FULL TREATMENT WAS DELIVERED AND RECORDED IN MOSAIQ. ELEKTA ARE UNABLE TO CONFIRM WHETHER ANY DOSE WAS DELIVERED DURING THE PERIOD WHEN MOSAIQ WAS RESTARTED AS NO TREATMENT RECORDS WERE RECEIVED. ELEKTA HAVE NOTIFIED THE CUSTOMER THAT IT IS RECOMMENDED THAT HITACHI VERIFY THAT NO METERSET WAS DELIVERED AT THAT TIME. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND WAS WORKING AS DESIGNED AND INTENDED.

    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 THE TREATMENT DOSE WAS NOT RECORDED IN MOSAIQ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064804 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB 07340201500071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown