BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPLAN RT DOSE 4.1.1

    MDR report key: 1628960 · Received March 10, 2010

    Report

    Report Number
    8043933-2010-00004
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    February 8, 2010
    Report Date
    February 9, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K080888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER DID NOT USE THE PLAN FOR PT TREATMENT. THERE HAS BEEN NO PT INJURY REPORTED BY ANY HOSPITAL; HOWEVER, A RISK TO PT HEALTH COULD NOT BE EXCLUDED. BRAINLAB INVESTIGATION HAS SHOWN THAT IPLAN RT DOSE 4.1.1 EXPORTS A TOO HIGH NUMBER OF MONITOR UNITS (MUS) IF ALL OF THE FOLLOWING CONDITIONS ARE MET: THE MULTI LEAF COLLIMATOR TYPE IS SIEMENS 160 MLC AND THE TREATMENT MODALITY IS IMRT AND THE PTV WIDTH IS LARGER THAN 200 MM AND THEREFORE THE IMRT FIELD IS SPLIT INTO SEVERAL "SPLIT-FIELDS" USING THE MLC CARRIAGE MOVEMENTS. BRAINLAB INTENDS THE FOLLOWING CORRECTIVE ACTIONS: POTENTIALLY AFFECTED CUSTOMERS RECEIVE A PRODUCT NOTIFICATION INFO (SEE ATTACHED). POTENTIALLY AFFECTED CUSTOMERS WILL RECEIVE A NEW CONFIGURATION-FILE THAT WILL DISABLE "SPLIT FIELDS" FOR SIEMENS 160 MLC MULTI LEAF COLLIMATORS. TENTATIVELY PLANNED AVAILABILITY: (B)(6) 2010. BRAINLAB WILL ACTIVELY CONTACT POTENTIALLY AFFECTED CUSTOMERS UPON AVAILABILITY TO IMPLEMENT THE ACCORDING NEW CONFIGURATION-FILE. CONCLUSION: THERE HAS BEEN NO PT INJURY REPORTED BY THIS OR ANY OTHER HOSPITAL, HOWEVER A RISK TO PT HEALTH COULD NOT BE EXCLUDED.

    Description of Event or Problem · 1

    AFTER EXPORTING A PLAN CREATED WITH THE BRAINLAB RADIOTHERAPY TREATMENT PLANNING SOFTWARE IPLAN RT DOSE TO THE RECORD & VERIFY SYSTEM, THE USER NOTICED THAT IPLAN RT DOSE EXPORTED A HIGHER NUMBER OF MONITOR UNITS (MUS) FOR PT IRRADIATION THAN INTENDED BY THE TREATMENT PLAN. ACCORDINGLY, THE USER DID NOT USE THE PLAN FOR PT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other