BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 18816425 · Received March 1, 2024

    Report

    Report Number
    3015232217-2024-00010
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    January 25, 2024
    Report Date
    May 30, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    PMA / PMN Number
    K183034
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 DATA PROVIDED BY THE CUSTOMER FOR INVESTIGATION IS INSUFFICIENT FOR DETERMINING THE DOSE DELIVERED TO THE FIELD SINCE THE SDD LOGS COVERING THE EVENT DATE ARE NOT AVAILABLE AND THE MACHINE LOG PROVIDED HAS NO RECORD OF THE PATIENT INVOLVED IN THE REPORTED EVENT. INVESTIGATION INTO THIS CASE CANNOT BE CONCLUDED DUE TO INSUFFICIENT INFORMATION AND THE CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY ARE NOT SURE IF PATIENT RECEIVED THE FULL DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298146 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown