BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 4252098 · Received November 14, 2014

    Report

    Report Number
    2950347-2014-00032
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    November 14, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS,INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LAB ORDER INTERFACE IS NOT SENDING A NOTIFICATION FOR CANCELLED ORDERS. THERE WAS NO MISTREATMENT REPORTED BASED ON THE AVAILABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737717 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1