BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 6131248 · Received November 29, 2016

    Report

    Report Number
    2950347-2016-00054
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Report Date
    November 29, 2016
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    UDI-DI
    00858164002091
    PMA / PMN Number
    K141572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE DEFECT WILL BE MONITORED AND RE-EVALUATED BASED ON THE POST MARKET DATA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN: ADJUSTING THE CHANGED DOSE DOES NOT PROPAGATE FOR THE ORDER FOR THE REST OF THE CARE PLAN, IT ONLY CHANGES THE ORDER FOR THE WINDOW THAT OPENED. BASED ON THE AVAILABLE INFORMATION, THERE HAS BEEN NO ACTUAL MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783007 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS, INC. 00858164002091

    Patients

    Seq Age Sex Outcome Treatment
    1