BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIGNRT

    MDR report key: 3633642 · Received December 18, 2013

    Report

    Report Number
    3004832819-2013-00002
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    November 19, 2013
    Report Date
    December 16, 2013
    Manufacturer
    VISION RT LTD
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHILST THERE IS NO EVIDENCE TO DATE WHETHER THE PROBLEM REPORTED IS AS A RESULT OF A GENUINE FAILING OF ALIGNRT OR USER ERROR, WE ARE NEVERTHELESS REPORTING THIS POTENTIAL MALFUNCTION TO THE FDA. OUR INVESTIGATION ON THIS MATTER IS CURRENTLY IS PROGRESS AND HAS NOT YET REACHED A FINAL CONCLUSION AS TO THE CAUSE.

    Description of Event or Problem · 1

    IN ORDER TO COMPARE A PATIENT'S POSITION AGAINST THEIR ASSOCIATED TREATMENT PLAN, THE USER IS ABLE TO IMPORT DICOM RT DATA (INCLUDING BOTH SURFACE CONTOURS AND ISOCENTRE INFORMATION) FROM THEIR TREATMENT PLANNING SYSTEM. THE CUSTOMER REPORTED THAT, PRIOR TO COMMENCING TREATMENT, THE THERAPIST OBSERVED THAT THE IMPORTED ISOCENTER POSITION DID NOT MATCH THE ISOCENTER POSITION IN THE TREATMENT PLAN. THE DICOM REFERENCE SURFACE WAS SUBSEQUENTLY RE-IMPORTED CORRECTLY, NO FURTHER ISSUES WERE IDENTIFIED AND TREATMENT COULD THEN BE COMMENCED CORRECTLY. THE ISSUE WAS IDENTIFIED PRIOR TO STARTING TREATMENT, HENCE THERE IS NO REPORTED PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664206 ALIGNRT PATIENT POSITIONING SYSTEM IYE VISION RT LTD ALIGNRT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK