BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 9124539 · Received September 26, 2019

    Report

    Report Number
    3003793371-2019-00001
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    August 27, 2019
    Report Date
    November 14, 2019
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K181145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VARIAN REF: (B)(4). VARIAN HAS NOW BEEN ABLE TO REPRODUCE THE ISSUE REPORTED BY THE CUSTOMER AND HAS DETERMINED THE ROOT CAUSE. OUR RISK ANALYSIS DETERMINED THAT THE ISSUE IS UNLIKELY TO LEAD TO SERIOUS HARM. THE SPECIFIC SEQUENCE OF EVENTS REQUIRED FOR THE INCORRECT DRR TO BE SAVED WITH THE PLAN MAKES THE ISSUE UNLIKELY TO OCCUR. HOWEVER, IF THE ISSUE DOES OCCUR, ANATOMICAL OUTLINES SUPERIMPOSED ON THE DRR WILL NOT OVERLAY THE ANATOMICAL STRUCTURES DISPLAYED IN THE DRR. IT IS THEREFORE HIGHLY LIKELY TO BE DETECTED EITHER DURING THE TREATMENT PLANNING PHASE OR WHEN THE PATIENT IS IMAGED PRIOR TO TREATMENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE ISOCENTER OF THE DIGITALLY RECONSTRUCTED RADIOGRAPH (DRR) IS DIFFERENT FROM THE ISOCENTER OF THE FIELD WITHIN THE PLAN. NO MISADMINISTRATION IS REPORTED.

    Additional Manufacturer Narrative · 1

    VARIAN REF: (B)(4). INVESTIGATION IS ON-GOING, AND HAS BEEN UNABLE TO REPRODUCE ISSUE TO DATE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ISOCENTER OF THE DIGITALLY RECONSTRUCTED RADIOGRAPH (DRR) IS DIFFERENT FROM THE ISOCENTER OF THE FIELD WITHIN THE PLAN. NO MISADMINISTRATION IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920635 ECLIPSE TREATMENT PLANNING SYSTEM MUJ VARIAN MEDICAL SYSTEMS H48

    Patients

    Seq Age Sex Outcome Treatment
    1