BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 10051891 · Received May 13, 2020

    Report

    Report Number
    2950347-2020-00016
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    March 10, 2020
    Report Date
    January 15, 2021
    Manufacturer
    ELEKTA INC
    Product Code
    IYE
    UDI-DI
    00858164002091
    PMA / PMN Number
    K141572
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER WAS NOTIFIED BY ANOTHER RADIOTHERAPY CENTRE (ROYAL MARSDEN NHS FOUNDATION TRUST) REGARDING THE BEHAVIOUR OF MOSAIQ KV-MV IGRT COUCH CORRECTION PROCESS AND THE CUSTOMER REPORTED THIS TO ELEKTA. ELEKTA CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL DATA REGARDING THE REPORTED MALFUNCTION ISSUE OF MOSAIQ KV IMAGE GUIDANCE CORRECTIONS ANOMALY AND THE CUSTOMER CONFIRMED THAT THE ANOMALY DID NOT OCCUR AND THAT THEY HAVE NOT HAD ANY MISTREATMENTS AS A RESULT OF THIS ISSUE. AN FCO-371-05-MSQ-025 (PRODUCT BULLETIN) WAS SENT TO THE CUSTOMER ON 20 APRIL 2020 WHICH ADDRESSED THIS ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MOSAIQ KV IMAGE GUIDANCE CORRECTIONS ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517626 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC MOSAIQ 00858164002091

    Patients

    Seq Age Sex Outcome Treatment
    1