BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEVATRON M2/PRIMUS MID-ENERGY

    MDR report key: 6912204 · Received October 3, 2017

    Report

    Report Number
    3002466018-2017-96369
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 14, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    IYE
    PMA / PMN Number
    K993425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS CONDUCTED A THOROUGH INVESTIGATION THAT SHOWS IN GENERAL ONLY THE ELECTRON MODE WAS AFFECTED AND THE PHOTON MODE WORKED PROPERLY. THE ELECTRON CHAMBER OF THE LINAC WAS DEFECTIVE AND AS SUCH, SYMMETRY AND FLATNESS INTERLOCKS OCCURED FOR ELECTRON TREATMENTS. DISABLING THE BEAM PROFILE INTERLOCKS BY SETTING SWI & FWI TO 100.0 CANNOT OCCUR ON ITS OWN. IT IS ASSUMED THAT THE RESPECTIVE SOFT-POD VALUES WERE MANIPULATED BY THE USER IN A SUCH A WAY THAT THE IRRADIATION OF ELECTRONS WAS POSSIBLE WITHOUT FLATNESS/SYMMETRY INTERLOCKS. AS A CONSEQUENCE, THE DOSE MONITORING SYSTEM WAS NOT WORKING PROPERLY FOR ELECTRON TREATMENTS. THE SYSTEM WORKED AS SPECIFIED AS IT PREVENTED ELECTRON IRRADIATION WHEN THE ELECTRON CHAMBER WAS DEFECTIVE BY PRODUCING INTERLOCKS. THE DEFECTIVE PART WAS REPLACED, WHICH IS NORMAL PROCEDURE FOR SUCH A SERVICE ISSUE. THE SYSTEM WAS BROUGHT INTO SPECIFICATION AND NO FURTHER CORRECTIVE ACTION IS INITIATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SIEMENS SERVICE ENGINEER (CSE) WAS ONSITE TO PERFORM AN UPDATE OF THE SYSTEM ON (B)(6) 2017 WHEN THE ONSITE PHYSICIST COMPLAINED ABOUT TOO LOW OF A DOSE RATE PERSISTING SINCE (B)(6) 2017. WHEN CHECKING THE SYSTEM PARAMETERS, THE CSE FOUND THAT AN UNAUTHORIZED PERSON HAD CHANGED THE SOFTPOT VALUES FOR THE PARAMETERS SWI AND FWI AT THE L PAGE (DOSE SET 1, PAGE 2). PARAMETERS HAD BEEN SET TO 100 BUT THEY SHOULD HAVE BEEN SET AT MAXIMUM 3.0. AFTER THE CSE CORRECTED THE VALUES THE SYSTEM DISPLAYED FLATNESS/SYMMETRY INTERLOCKS. THE CSE DETECTED THAT TWO SEGMENTS OF THE ELECTRON CHAMBER WERE DEFECTIVE. THIS WAS THE REASON THE SYSTEM DISPLAYED THE INTERLOCKS AND PREVENTED FURTHER USE OF THE ELECTRON MODE. THE CSE REPORTED THAT AN UNAUTHORIZED PERSON MUST HAVE TAMPERED WITH THE SYSTEM IN SUCH WAY THAT THE AFOREMENTIONED SAFETY INTERLOCKS WOULD NO LONGER BE DISPLAYED. THE CUSTOMER REPORTED THAT APPROXIMATELY FIFTEEN (15) PATIENTS PER DAY HAD BEEN TREATED WITH THIS CONFIGURATION SINCE (B)(6) 2017 HOWEVER IT COULD NOT BE DETERMINED WHEN THE INCORRECT VALUE FOR THE PARAMETERS SWI AND FWI WERE ACTUALLY SET. THERE IS NO REPORT OF MISTREATMENT OR INJURY TO A PATIENT. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692645 MEVATRON M2/PRIMUS MID-ENERGY ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS HEALTHCARE GMBH 1940035

    Patients

    Seq Age Sex Outcome Treatment
    1