BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 3888573 · Received April 24, 2014

    Report

    Report Number
    2950347-2014-00017
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K123230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AUTOMATIC TABLE MOVEMENT, THE TABLE HAS MOVED TO AN INCORRECT POSITION. THERE WAS NO ACTUAL MISTREATMENT REPORTED AS A RESULT OF THIS ISSUE BASED ON THE AVAILABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248229 MOSAIQ MOSAIQ ONCOLOGY INFORMATION SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1