BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY1.1

    MDR report key: 3169241 · Received June 14, 2013

    Report

    Report Number
    9617016-2013-00009
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    February 12, 2014
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    PMA / PMN Number
    K112613
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS INCIDENT IS ON-GOING AT THIS TIME. ONCE THE INVESTIGATION IS COMPLETE, ELEKTA WILL FORWARD ADDITIONAL INFORMATION TO THE FDA.

    Additional Manufacturer Narrative · 1

    MISTREATMENT WAS A 30MU UNDER DOSE. A COURSE OF IMRT FOR THE PROSTATE TYPICALLY INVOLVES A TOTAL DOSE OF 64GY AND ABOVE. 30MU REPRESENTS A VERY SMALL PERCENTAGE. CLINICIANS ARE UNLIKELY TO TAKE CORRECTIVE ACTION FOR SUCH A SMALL UNDER DOSE. NO FURTHER INFORMATION RECEIVED FROM THE HOSPITAL ON THE PATIENT OUTCOME. THE MANUFACTURER HAS COMPLETED IT'S INVESTIGATION. IT HAS NOT BEEN POSSIBLE TO REPRODUCE THE ISSUE OF THE NETWORK FAILURE AND AN ANALYSIS OF THE LOG FILES DID NOT LEAD TO THE ROOT CAUSE BEING FOUND. NO FURTHER INCIDENTS HAVE OCCURRED SINCE THE SITE TURNED OFF INTELLIMAX. THE CUSTOMER HAS BEEN ADVISED TO CONSIDER UPGRADING TO THE LATEST INTELLIMAX AGENT. THE SITE IS NOT USING A STANDARD NETWORK CONFIGURATION. ALL ELEKTA LINACS ARE CONNECTED TO THE SAME VIRTUAL NETWORK AND IT HAS BEEN RECOMMENDED TO INSTALL AN NSS FOR EACH MACHINE. THIS IS THE MANUFACTURER'S FINAL REPORT.

    Description of Event or Problem · 1

    DUE TO NETWORK FAILURE THE PATIENT MAY HAVE BEEN UNDERDOSED, HOWEVER, WE ARE UNSURE WHETHER THE DOSE WAS WITHIN CLINICALLY ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270474 INTEGRITY1.1 ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1