BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 5083462 · Received September 17, 2015

    Report

    Report Number
    2950347-2015-00027
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 10, 2015
    Report Date
    May 23, 2018
    Manufacturer
    ELEKTA INC
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH AN OFFSET ISOCENTER OF 3 CM TABLE HEIGHT WITH RESPECT TO THE THEORETICAL ISOCENTER. BASED ON THE AVAILABLE INFORMATION, THERE WAS A MISTREATMENT, HOWEVER THE CUSTOMER HAS STATED THAT "MINOR DOSIMETRIC IMPACT EXPECTED WITHOUT CLINICAL CONSEQUENCE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616275 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC

    Patients

    Seq Age Sex Outcome Treatment
    1