BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 5716644 · Received June 10, 2016

    Report

    Report Number
    2950347-2016-00030
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    April 8, 2016
    Report Date
    September 19, 2016
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF SCREEN SHOTS SUPPLIED BY THE CUSTOMER WAS PERFORMED AS PART OF THE INVESTIGATION FOR THIS. IT APPEARS THAT THE USER HAD SELECTED THE WRONG UNITS US VS. SI IN THE VITALS/LAB DATA DIALOG BOX. THIS SELECTION IS DONE BY USING RADIO BUTTONS. THERE MAY HAVE BEEN A MISTREATMENT HOWEVER IT WAS DUE TO USER ERROR. IT SHOULD BE OBVIOUS THAT THE BSA CALCULATED IS NOT CORRECT.. THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. MOSAIQ IS WORKING AS DESIGNED AND INTENDED. THE VITALS/LAB DATA WINDOW DEFAULTS TO US STANDARD UNITS FOR WEIGHT AND HEIGHT. THE "US STANDARD" CHOICE IS CLEARLY INDICATED (RADIO BUTTON SELECTED) AND THE UNITS ON WEIGHT (LB) AND HEIGHT (IN) ARE ALSO CLEARLY LABELED. IN SPITE OF THIS, THE USER ENTERED KG AND CM VALUES WHICH RESULTED IN AN INCORRECT DOSE. THEREFORE THIS ISSUE WAS A RESULT OF HUMAN ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN CALCULATING THE BSA FOR CHEMOTHERAPY MOSAIQ DEFAULTS TO IMPERIAL MEASUREMENTS. THE CUSTOMER WORKS WITH METRIC MEASUREMENTS AND HAS ENTERED THESE VALUES INTO THE IMPERIAL MEASUREMENT FIELDS. BASED ON THE AVAILABLE INFORMATION A MISTREATMENT MAY HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372976 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other