BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 3853454 · Received April 4, 2014

    Report

    Report Number
    2950347-2014-00016
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K123230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COUCH ANGLE COULD BE MODIFIED IN MOSAIQ BUT THE TREATMENT DELIVERED WOULD USE THE ORIGINAL UNMODIFIED COUCH ANGLE. THERE WAS NO ACTUAL MISTREATMENT. THIS ISSUE WAS FOUND INTERNALLY, DURING AD HOC TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203562 MOSAIQ MOSAIQ ONCOLOGY INFORMATION SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1