BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 6979012 · Received October 26, 2017

    Report

    Report Number
    2950347-2017-00021
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Report Date
    February 19, 2018
    Manufacturer
    ELEKTA INC.
    Product Code
    IYE
    UDI-DI
    00858164002091
    PMA / PMN Number
    K141572
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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

    UPDATED INITIAL REPORTER DETAILS. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE ISSUE THAT THE USER WAS EXPERIENCING WITH THE DEVICE WAS INCORRECT SHIFTS. THIS ISSUE HAS BEEN ATTRIBUTED TO THE USE OF 40X20CM MV IMAGES RESULTING IN THE AUTO-ISOCENTRE NOT FUNCTIONING AS INTENDED. ABNORMAL USE. AN ELEKTA TRAINING SPECIALIST ATTENDED THE SITE ON 21 DECEMBER 2017 AND OFFERED ADVICE ON HOW TO OPTIMISE THE WORKFLOW ON ELEKTA EQUIPMENT TO PREVENT THIS.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED INCORRECT DIRECTION SHIFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760233 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC. 00858164002091

    Patients

    Seq Age Sex Outcome Treatment
    1