BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCEANTRA MASTERPLAN

    MDR report key: 2396643 · Received December 23, 2011

    Report

    Report Number
    9611894-2011-00017
    Event Type
    Other
    Date Received
    December 23, 2011
    Date of Event
    February 4, 2011
    Report Date
    December 23, 2011
    Manufacturer
    NUCLETRON, B.V.
    Product Code
    JAQ
    PMA / PMN Number
    K081281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NUCLETRON SENT A CUSTOMER INFORMATION BULLETIN 555.00183 TO THEIR USERS WITH HOW AN ADDITIONAL SAFEGUARD CAN BE APPLIED IN ONCENTRA MASTERPLAN. AS A RESULT OF THE FDA FORM 483 REPORT FEI NUMBER (B)(4) DATED 10/28/2011, NUCLETRON (B)(4) IS NOW SUBMITTING THIS MDR IN COMPLIANCE WITH THE CORRECTIVE ACTIONS OF THE FDA FORM 483.

    Description of Event or Problem · 1

    WHEN HAVING PLAN ANALYSIS OR PLAN MANAGER OPEN WHEN CHANGING VOXEL SIZE FOR A ROI IN AM, THE DOSE STATISTICS IN THE CASE EXPLORER IS NOT UPDATED UNTIL THE MODULE IS CLOSED AND OPEN AGAIN. IN ADDITION, THE DOSE STATISTICS IN THE PM TREATMENT PRINTOUT IS INCORRECT IN THE SAME WAY, AND IF A PLAN IS NORMALIZED TO THAT ROI, THE MU AND DOSE VALUE WILL BE INCONSISTENT UNTIL THE MODULE IS CLOSED AND OPEN AGAIN. THE DVH CURVES AND THE TREATMENT PRINTOUT ARE STILL CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCEANTRA MASTERPLAN OTP SOFTWARE JAQ NUCLETRON, B.V. 170.700-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA