BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCENTRA MASTERPLAN

    MDR report key: 2422853 · Received December 23, 2011

    Report

    Report Number
    9611894-2011-00023
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    December 23, 2011
    Manufacturer
    NUCLETRON, BV
    Product Code
    MUJ
    PMA / PMN Number
    K081281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCENTRA HAS AN APPROVAL MECHANISM AND IT'S CLEARLY STATED IN THE DOCUMENTATION THAT ONLY APPROVED PLANS SHOULD BE USED FOR TREATMENT. THE USER HAS NOT FOLLOWED THESE INSTRUCTIONS. ONCENTRA DOES NOT ALLOW TO APPROVE PLANS WITHOUT DOSE. AS A RESULT OF THE FDA FORM 483 REPORT FEI NUMBER (B)(4) DATED (B)(4) 2011, NUCLETRON BV IS NOW SUBMITTING THIS MDR IN COMPLIANCE WITH THE CORRECTIVE ACTIONS OF THE FDA FORM 483.

    Description of Event or Problem · 1

    ONCENTRA ALLOWS TO EXPORT UNAPPROVED PLANS WITHOUT DOSE FOR USER WORKFLOW REASONS. THE UNAPPROVED PLAN WAS USED FOR BEAM SETUP AND CONSEQUENTLY FOR TREATMENT. THIS RESULTED UNINTENDED IN 2 BEAMS WITH 100MU EACH. THIS COULD ALMOST COMPLETELY BE COMPENSATED DURING THE FOLLOWING TREATMENTS, AND THE DEVIATION FROM THE PRESCRIBED DOSE WAS VERY SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCENTRA MASTERPLAN OTP SOFTWARE MUJ NUCLETRON, BV 170.700-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA