BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBEAM PROTON THERAPY SYSTEM

    MDR report key: 3949376 · Received May 2, 2014

    Report

    Report Number
    3008889206-2014-00001
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Product Code
    LHN
    PMA / PMN Number
    K133191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON OUR PRELIMINARY INVESTIGATION: AN UNRECOVERABLE SYSTEM INTERRUPT OCCURRED DURING A PATIENT TREATMENT AND THE TREATMENT RECORD WAS NOT AUTOMATICALLY WRITTEN BACK TO THE ONCOLOGY INFORMATION SYSTEM (OIS). THE USER MANUALLY INPUTTED THE TREATMENT RECORD INTO THE OIS. IN THIS CASE, THE OIS ASSUMED THAT THE PARTIALLY DELIVERED DOSE WAS ADMINISTERED IN THE ORDER PRESCRIBED IN THE TREATMENT PLANNING SYSTEM. SINCE THE SCANNING SYSTEM RE-ORDERS THE SPOTS, THIS COULD LEAD TO THE WRONG SPOT DISTRIBUTION IN THE AFFECTED LAYER. THIS EVENT DID NOT RESULT IS A MISADMINISTRATION OR A PATIENT HARM. THIS FAILURE MODE COULD POTENTIALLY CAUSE HARM IF THE INTERRUPTION WERE TO OCCUR DURING A STEREO-TACTIC TREATMENT. PLEASE NOTE THERE IS ONLY ONE PROBEAM SITE (DEVICE) IN THE U.S. THERE HAVE BEEN NO STEREO-TACTIC TREATMENTS PLANNED OR CONDUCTED, AND THERE ARE NO IMMEDIATE PLANS TO PERFORM THIS TREATMENT MODALITY AT THIS FACILITY. (B)(4).

    Description of Event or Problem · 1

    THE SYSTEM DELIVERED PART OF THE PRESCRIBED TREATMENT DOSE WHEN A SYSTEM INTERLOCK OCCURRED. WHEN THE SYSTEM WAS RESET, THE CUSTOMER OBSERVED THAT THE TREATMENT CONSOLE DID NOT SHOW THE PARTIALLY DELIVERED DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265660 PROBEAM PROTON THERAPY SYSTEM SYSTEM, RADIATION THERAPY LHN PROBEAM NA

    Patients

    Seq Age Sex Outcome Treatment
    1