BEUDAMED
    FDA Adverse Event Other Summary report: N

    IPLAN RT DOSE 4.1.1.

    MDR report key: 1642849 · Received March 25, 2010

    Report

    Report Number
    8043933-2010-00005
    Event Type
    Other
    Date Received
    March 25, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 1, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K080888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER DID NOT USE THE PLAN FOR PATIENT TREATMENT. THERE HAS BEEN NO PATIENT INJURY REPORTED BY ANY HOSPITAL, HOWEVER, A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED. BRAINLAB INVESTIGATION HAS SHOWN THAT IPLAN RT DOSE 4.1.1 ERRONEOUSLY IGNORES A ROTATION PARAMETER REQUIRED FOR CORRECT MONTE CARLO DOSE CALCULATION. THIS MAY RESULT IN A DOSE DISTRIBUTION DIFFERENT FROM THE ONE INITIALLY INTENDED. THERE ARE CASES WERE A CLINICALLY RELEVANT DEVIATION CANNOT BE RULED OUT. BRAINLAB INTENDS THE FOLLOWING CORRECTIVE ACTIONS: POTENTIALLY AFFECTED CUSTOMERS RECEIVE A PRODUCT NOTIFICATION INFORMATION. POTENTIALLY AFFECTED CUSTOMERS WILL RECEIVE A SOFTWARE UPDATE. TENTATIVELY PLANNED AVAILABILITY: AUGUST 2010. BRAINLAB WILL ACTIVELY CONTACT POTENTIALLY AFFECTED CUSTOMERS UPON AVAILABILITY OF THE SOFTWARE UPDATE.

    Description of Event or Problem · 1

    UNDER CERTAIN CIRCUMSTANCES IPLAN RT DOSE ERRONEOUSLY IGNORES A ROTATION PARAMETER REQUIRED FOR CORRECT MONTE CARLO DOSE CALCULATION. THIS MAY RESULT IN A DOSE DISTRIBUTION DIFFERENT FROM THE ONE INITIALLY INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPLAN RT DOSE 4.1.1. RADIOTHERAPY TREATMENT PLANNING SW MUJ BRAINLAB AG 4.1.1. NA

    Patients

    Seq Age Sex Outcome Treatment
    1