BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 11744319 · Received April 29, 2021

    Report

    Report Number
    11744319
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 28, 2021
    Manufacturer
    ELEKTA, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN MIDDLE OF TREATMENT AND MOSAIQ, THE RECORD AND VERIFY SYSTEM, WAS DISCONNECTED. WE WERE SOON NOTIFIED THE ELEKTA CLOUD WAS PULLED OFFLINE DUE TO POTENTIAL COMPROMISE TO THEIR SYSTEM. ALL PATIENTS FROM 3PM ON HAVE BEEN CANCELED AND WILL BE RESCHEDULED ONCE WE ARE MADE AWARE THAT MOSAIQ IS BACK ONLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645780 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA