BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 3955536 · Received June 12, 2014

    Report

    Report Number
    2950347-2014-00022
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K123230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MOSAIQ VERSION 2.60.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE USER SELECTS 'MAIL TO' FROM A NOTE, THE MAIL MESSAGE FORM IS OPENED UP FOR THE WRONG PT AND NOTE. THERE WAS NO ACTUAL MISTREATMENT. THIS ISSUE WAS FOUND INTERNALLY, DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348140 MOSAIQ MOSAIQ ONCOLOGY INFO SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1