BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 6002974 · Received October 6, 2016

    Report

    Report Number
    2950347-2016-00048
    Event Type
    Injury
    Date Received
    October 6, 2016
    Report Date
    January 25, 2017
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 1

    MANUFACTURERS NARRATIVE - INVESTIGATION FINDINGS: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. ENGINEERING ANALYSIS INDICATES USER ERROR. THE USER DID NOT CLICK OK IN THE IMAGE REVIEW WINDOW SO THE FIRST SHIFT WAS NOT SAVED INTO THE DATABASE. RECOMMENDATION IS FOR THE USER TO BE SURE TO CLICK OK IN THE IMAGE REVIEW WINDOW, THIS PROCESS IS DOCUMENTED. THE DEVICE IS WORKING AS DESIGNED AND INTENDED. SPECIFIC TRAINING MATERIALS HAVE BEEN PLACED IN SUPPORT PLUS FOR CUSTOMERS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT A PATIENT HAS BEEN MISTREATED DUE TO THE WRONG IMAGE BEING VERIFIED IN MOSAIQ. BASED ON THE AVAILABLE INFORMATION MISTREATMENT OCCURRED, WHICH COULD POSSIBLY RESULT IN SERIOUS CLINICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654043 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other