BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 7094730 · Received December 7, 2017

    Report

    Report Number
    2950347-2017-00030
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 9, 2017
    Report Date
    January 29, 2019
    Manufacturer
    ELEKTA INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIST

    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

    UPDATED WITH UDI NUMBER. THE ISSUE CANNOT BE REPRODUCED INTERNALLY AND THE CUSTOMER WAS UNABLE TO PROVIDE THE STEPS THEY USED TO REPRODUCE THE PROBLEM. IT IS CONCLUDED THAT MOSAIQ IS WORKING AS DESIGNED AND INTENDED AND THIS IS USER ERROR. BASED ON THE AVAILABLE INFORMATION, A PATIENT WAS MISTREATED IN THIS CASE. THE MISTREATMENT COULD POSSIBLY LEAD TO SERIOUS INJURY. THIS FOLLOW-UP #1 REPORT WAS SUBMITTED ON 26 JANUARY 2018, UNDER THE WRONG MFR REPORT NUMBER DUE TO AN ADMINISTRATIVE ERROR. IT WAS REPORTED UNDER MFR NO. 2950347-2018-00030, BUT SHOULD HAVE BEEN REPORTED UNDER MFR NO. 2950347-2017-00030.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A WRONG SHIFT FROM XVI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877721 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other