BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 8873345 · Received August 8, 2019

    Report

    Report Number
    2950347-2019-00010
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    July 2, 2019
    Report Date
    November 28, 2019
    Manufacturer
    ELEKTA INC
    Product Code
    IYE
    UDI-DI
    00858164002091
    PMA / PMN Number
    K141572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE PATIENT RECEIVED TREATMENT DELIVERED FROM RADIATION FIELDS THAT WERE INTENDED FOR ANOTHER PATIENT. NO IMPAIRMENT OR DAMAGE IS EXPECTED FROM THIS EVENT HOWEVER A CHANGE WAS MADE TO THE PATIENT'S PRESCRIPTION, IN ORDER TO COMPENSATE FOR THE EVENT. THE PATIENT WAS TREATED IN QA MODE. ELEKTA WERE UNABLE TO REPRODUCE THE PROBLEM, BUT IF THIS ISSUE WERE TO REOCCUR IT COULD LEAD TO SERIOUS INJURY.

    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 THAT WHEN OPENING A PATIENT DATA SET, THE WRONG PATIENT CHART IS OPENING. BASED UPON THE AVAILABLE INFORMATION ACTUAL MISTREATMENT TO PATIENT WOULD NOT HAVE SUSTAINED SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667602 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC MOSAIQ 00858164002091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other