BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 3955545 · Received June 12, 2014

    Report

    Report Number
    2950347-2014-00021
    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
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: MOSAIQ VERSION 2.06.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 'VIEWING CORRECTED INTERFACED LABS' ON FLOWSHEET WITH 'DISPLAY DESCENDING DATES' OPTION ON, THE MOST RECENT VALUES/CORRECTIONS ARE NOT DISPLAYED. THE OLDER VALUES ARE DISPLAYED INSTEAD. THERE WAS NO ACTUAL MISTREATMENT REPORTED AS A RESULT OF THIS ISSUE BASED ON THE AVAILABLE INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347840 MOSAIQ MOSIAQ ONCOLOGY INFO SYSTM IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1