BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISTE MV SYSTEM

    MDR report key: 4792566 · Received May 11, 2015

    Report

    Report Number
    2240869-2015-10360
    Event Type
    Malfunction
    Date Received
    May 11, 2015
    Date of Event
    April 2, 2015
    Report Date
    April 9, 2015
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K103606
    Removal / Correction Number
    2240869-08/05/15-0023-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION SHOWED THAT THE TREATMENT WAS DELIVERED BY A LINAC THAT HAD TECHNICAL ISSUES, CAUSING SEVERAL INTERRUPTIONS OF THE TREATMENT IN ONE SINGLE BEAM. IN THIS CASE, THE OPERATOR USED IN-SESSION RESUMPTION TO CONTINUE TREATMENT, WHICH RESULTED IN OVERDOSE TO THE PATIENT FOR MULTIPLE SEGMENTS (2-6) OF ONE IMRT BEAM OF A FRACTIONATED TREATMENT HAVING BEEN DELIVERED TWICE. SIEMENS HAS INITIATED A CORRECTIVE ACTION IN THE FORM OF AN UPDATE INSTRUCTION (TH001/15/S - RTT 4.3.1MR2 HARMONIZATION SOFTWARE UPDATE) THAT RESOLVES THIS ISSUE OF WRONG IN-SESSION RESUMPTION AND WAS RELEASED FOR DISTRIBUTION TO AFFECTED CUSTOMERS IN JULY 2015.

    Additional Manufacturer Narrative · 1

    SIEMENS BECAME AWARE OF THE REPORTED EVENT ON (B)(6) 2015, AND THIS MDR IS BEING MAILED ON (B)(6) 2015. INVESTIGATION IS ON-GOING AND A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(6) 2015, THAT AFTER AN IMRT TREATMENT, MOSAIQ RECORDED 20MU TOO MUCH FOR FIELD NO. 7. THE DOSE RECORDED IN MOSAIQ FOR FIELD NO 7 HAS BEEN CHANGED FROM 0, 34 TO 0, 26 RETROACTIVELY BY THE CUSTOMER. REPORTEDLY, MULTIPLE SEGMENTS (2-6) OF ONE IMRT BEAM OF A FRACTIONATED TREATMENT HAD BEEN DELIVERED TWICE. THIS REPORTED ISSUE OCCURED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306013 ARTISTE MV SYSTEM IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 08139789 NA

    Patients

    Seq Age Sex Outcome Treatment
    1