BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSIAQ

    MDR report key: 3955544 · Received June 12, 2014

    Report

    Report Number
    2950347-2014-00020
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K123230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MED DEVICE: MOSAIQ VERSION 2.30.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER CAN ADD A SITE SETUP AND IMPORT A SITE SETUP AT THE SAME TIME, RESULTING IN TWO SITE SETUP FOR THE SAME TREATMENT SITE. THERE WAS NO ACTUAL MISTREATMENT REPORTED AS A RESULT OF THIS ISSUE BASED ON THE AVAILABLE INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348822 MOSIAQ MOSAIQ ONCOLOGY INFO SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1