BEUDAMED
    FDA Adverse Event Summary report: N

    MOSAIQ

    MDR report key: 5083453 · Received September 17, 2015

    Report

    Report Number
    2950347-2015-00026
    Date Received
    September 17, 2015
    Report Date
    January 28, 2016
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S FINAL INVESTIGATION CONCLUDED THAT THE AUTOMATED TABLE MOVEMENT (ATM) FUNCTION IS WORKING AS INTENDED. ATM MAXIMUM VALUES ARE HIGHLIGHTED IN RED IF OFFSET VALUES ARE OUTSIDE THE TOLERANCE VALUES SPECIFIED FOR EACH PARAMETER. THE RED HIGHLIGHT IS NOT AN INTERLOCK, BUT A WARNING FLAG TO DRAW AWARENESS TO THE USER. BY DESIGN, OFFSET VALUES OUTSIDE OF TOLERANCE WILL NOT BE SENT TO THE MACHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATM VALUE THAT IS OVER THE MAXIMUM IS ALLOWED TO BE TREATED. BASED ON THE AVAILABLE INFORMATION, THERE WAS NO REPORT OF MISTREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATM VALUE THAT IS OVER THE MAXIMUM IS ALLOWED TO BE TREATED. BASED ON THE AVAILABLE INFORMATION, THERE IS NO REPORT OF MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615788 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1