BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 6072129 · Received November 2, 2016

    Report

    Report Number
    2950347-2016-00052
    Event Type
    Injury
    Date Received
    November 2, 2016
    Report Date
    November 2, 2016
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIST

    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 USER ERROR. THE PRODUCT IS WORKING AS DESIGNED AND INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT WAS TREATED USING ANOTHER PATIENT'S PLAN. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN AN ACTUAL MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723959 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other