BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS BRAND NAME: MEVATRON

    MDR report key: 2258094 · Received August 15, 2011

    Report

    Report Number
    2910081-2011-00039
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K882729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY RISK ASSESSMENT INDICATES: SEVERITY: 3 (CRITICAL). THERE HAS BEEN NO MISTREATMENT OR INJURY REPORTED. THE THERAPIST NOTICED A SMALL DEVIATION OF THE X2 FIELD DURING SETUP OF THE 3RD PT AND DI NOT CONTINUE TREATMENT. CASE 1: 2 (MODERATE). WHEN THERE IS ONLY A SMALL DEVIATION FROM THE PLANNED FIELD SHAPE, IT IS POSSIBLE THAT IT WILL NOT BE NOTICED BY THE CUSTOMER UNTIL THE NEXT MORNING CHECK. THIS MAY POTENTIALLY RESULT IN A SMALL DEVIATION FROM THE TREATMENT FIELD (DOSE TO WRONG LOCATION) FOR ONE FRACTION. CASE 2: 3 (CRITICAL). IN WORST CASE, THERE MAY BE AN INCORRECT SETTING FOR THE POT/ENCODER MISMATCH TOLERANCE AND THE DAILY QA PROCEDURES MAY NOT BE PERFORMED. IN THIS CASE IT MAY POTENTIALLY HAPPEN, THAT AN ISSUE WITH THE MLC CAUSES. PROBABILITY: PRELIMINARY C (REMOTE). CASE 1: D (OCCASIONALLY). IT MAY HAPPEN THAT A PT IS TREATED WITH A WRONG FIELD SHAPE FOR ONE FRACTION IF THE TOLERANCE FOR POT/ENCODER MISMATCH IS SET TO A WRONG VALUE. CASE 2 (WORST CASE): C (REMOTE). IF THERE IS AN INCORRECT SETTING FOR THE POT/ENCODER MISMATCH TOLERANCE AND THERE IS AN ISSUE WITH THE MCL THE ISSUE WILL BE FOUND WHEN PERFORMING DAILY QA PROCEDURES. EVEN IF THE DEPARTMENT DOES NOT PERFORM A DAILY QA THE ISSUE WILL BE RECOGNIZED DURING PT SET UP USING IMAGING OPTIONS OR. NO OTHER PRODUCTS ARE CONCERNED.

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN IDENTIFIED WITH OUR MEVATRON LINEAR ACCELERATOR. IN THE ABUNDANCE OF CAUTION THIS PRODUCT PROBLEM IS BEING REPORTED. DURING SETTING UP OF A THIRD PT IN THE MORNING IT WAS FOUND BY OUR CUSTOMER THAT THE X2 FIELD WAS 0.5 CM LARGER THAN WHAT WAS SHOWN ON THE DISPLAY AND THAT NO INTERLOCKS WERE SHOWING. OUR CUSTOMER REMOVED THE PT FROM THE ROOM AND RAN THE MACHINE AND CALLED SERVICE ONCE THEY VERIFIED THAT THE MACHINE DIDN'T PRODUCE AN INTERLOCK. THE THERAPISTS HAD DONE THEIR MORNING CHECKS AND ALL WERE OK ACCORDING TO THEM. THE FINAL CORRECTIVE ACTION IS PENDING RESULTS OF OUR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS BRAND NAME: MEVATRON ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1