BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 4594781 · Received March 4, 2015

    Report

    Report Number
    2950347-2015-00006
    Event Type
    Malfunction
    Date Received
    March 4, 2015
    Date of Event
    January 5, 2015
    Report Date
    March 4, 2015
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K123230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT AND WILL BE FIXED IN A LATER VERSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IVIEW ISOCENTER (ELECTRONIC GRATICULE) IS NOT CORRECT FOR FLD 1A ON IMAGE ACQUIRED (B)(6) /2015 AND FLD 1B ON IMAGE ACQUIRED ON (B)(6) /2015. THERE WAS NO REPORT OF MISTREATMENT BASED ON THE AVAILABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149383 MOSAIQ IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1