BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 3601759 · Received January 17, 2014

    Report

    Report Number
    2950347-2014-00005
    Event Type
    Injury
    Date Received
    January 17, 2014
    Date of Event
    February 12, 2013
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RADIATION TREATMENT FRACTION WAS MISDIRECTED. THE INITIAL ASSESSMENT OF THIS FIELD PLACEMENT ERROR IS ESTIMATED TO BE APPROXIMATELY 6.6CM SUPERIORLY WITH RESPECT TO THE TREATMENT ISOCENTER. THE POSITIONING ERROR RESULTED FROM AN AUTOMATED SHIFT OF THE TREATMENT COUCH ON THE LINEAR ACCELERATOR BY A MAGNITUDE OF 3.3CM, IN A DIRECTION OPPOSITE TO THAT INTENDED, RESULTING IN A TOTAL ERROR OF 6.6CM WHICH IS A CATEGORISED A GEOGRAPHIC MISS IN THIS CASE. HISTORICAL TREATMENT DATA WOULD INDICATE THAT TWO SIMILAR INCIDENTS, UNDER SIMILAR CIRCUMSTANCES, ARE ALSO LIKELY TO HAVE OCCURRED; HOWEVER, NO FURTHER INFO WAS AVAILABLE. IT IS UNK AT THIS TIME IF THE PRODUCT MALFUNCTIONED. NO FURTHER INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44500 MOSAIQ ONCOLOGY INFORMATION SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other