BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 3601760 · Received January 17, 2014

    Report

    Report Number
    2950347-2014-00002
    Event Type
    Injury
    Date Received
    January 17, 2014
    Report Date
    January 17, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K123230
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: DEVICE VERSION 2.0.

    Description of Event or Problem · 1

    THE FOLLOWING ISSUES WERE REPORTED: DURING IMRT TREATMENTS, WHEN MOSAIQ RECOVERS FROM AN ERROR, TOTAL MU IS RE-DISTRIBUTED OVER ALL SEGMENTS, INCLUDING THE SEGMENTS THAT WERE TREATED INSTEAD OF PARTIAL TREATMENT. CUSTOMER IS EXPERIENCING MULTIPLE BEAM OR SESSION TERMINATIONS. FINISHED FIELD IS NOT BEING DELIVERED CORRECTLY. AVAILABLE DATA INDICATES POTENTIAL MISTREATMENTS THAT ARE PRESUMED TO HAVE RESULTED IN SERIOUS INJURY; HOWEVER, NO KNOWN IMPACT TO PATIENTS HAVE BEEN REPORTED. NO FURTHER INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44557 MOSAIQ ONCOLOGY INFO SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other