BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

    MDR report key: 8736109 · Received June 26, 2019

    Report

    Report Number
    3004022368-2019-00001
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Report Date
    May 30, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K041577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE AS REPORTED FROM THE CUSTOMER IS NOT REPRODUCIBLE. THE CUSTOMER UTILIZED CUSTOM SCRIPTS TO CREATE THE TREATMENT PLAN, THOSE SCRIPTS WERE PROVIDED AND EVALUATED BUT THE ISSUE COULD NOT BE REPLICATED. THE CUSTOMER COULD NOT REPLICATE THIS ISSUE FROM SCRATCH. THE CUSTOMER, NOR THE INVESTIGATORS HERE AT PHILIPS ARE ABLE TO GET THE PLAN IN THIS STATE AGAIN. THE CUSTOMER SENT THE PLAN, AND WE CAN CONFIRM THE PLAN IS IN THE STATE. ONCE BEAMS ARE RECALCULATED, THE STATE GOES AWAY. IT WOULD ALSO BE VISIBLE IN QA, ON A PHANTOM FOR EXAMPLE OR OTHER WAY OF EVALUATING THE DOSE. EVEN IF IT OCCURRED IN A SITUATION WHERE 1 OR 2 TREATMENTS HAD OCCURRED, IT COULD BE CORRECTED FOR THE REMAINDER OF THE COURSE OF THERAPY. ANY PATIENT INVOLVEMENT WOULD BE NO OR MINIMAL HARM IF IT WERE CAUGHT AFTER 2-3 FRACTIONS OF TREATMENT. THERE WAS NO PATIENT MISTREATMENT NOR PATIENT HARM RELATED TO THIS ISSUE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    DOSE OF COMPUTED BEAMS IS NOT BEING DISPLAYED. USER SHARED A PLAN WITH 5 3D-CRT (OPEN) AND 3 IMRT BEAMS, WHERE TWO OF THE OPEN BEAMS, EVEN THOUGH THEY ARE SHOWN AS COMPUTED, NO DOSE IS BEING DISPLAYED FOR THEM. MONITOR UNITS ARE PROVIDED FOR THESE TWO BEAMS. WHEN THEY EXPORTED THE PLAN AND VERIFIED IN THEIR INDEPENDENT MONITOR UNIT CALCULATION SYSTEM THEY DISCOVERED AN OVER-DOSAGE OF 22GY (112%) IN THE TARGET VOLUME. ISSUE WAS DETECTED BY EXPORTING THE PLAN TO A SECONDARY DOSE CALCULATION SYSTEM ¿ MOBIUS. NO PATIENTS TREATED. ON RECALCULATING THE TWO BEAMS IN PINNACLE DOSE IS UPDATED TO INCLUDE THE CONTRIBUTION OF THESE TWO BEAMS.

    Description of Event or Problem · 1

    DOSE OF COMPUTED BEAMS IS NOT BEING DISPLAYED. USER SHARED A PLAN WITH 5 3D-CRT (OPEN) AND 3 IMRT BEAMS, WHERE TWO OF THE OPEN BEAMS, EVEN THOUGH THEY ARE SHOWN AS COMPUTED, NO DOSE IS BEING DISPLAYED FOR THEM. MONITOR UNITS ARE PROVIDED FOR THESE TWO BEAMS. WHEN THEY EXPORTED THE PLAN AND VERIFIED IN THEIR INDEPENDENT MONITOR UNIT CALCULATION SYSTEM THEY DISCOVERED AN OVER-DOSAGE OF 22GY (112%) IN THE TARGET VOLUME. ISSUE WAS DETECTED BY EXPORTING THE PLAN TO A SECONDARY DOSE CALCULATION SYSTEM ¿ MOBIUS. NO PATIENTS TREATED. ON RECALCULATING THE TWO BEAMS IN PINNACLE DOSE IS UPDATED TO INCLUDE THE CONTRIBUTION OF THESE TWO BEAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531432 SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING MUJ PHILIPS MEDICAL SYSTEMS 459800614511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other