BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE

    MDR report key: 17831550 · Received September 28, 2023

    Report

    Report Number
    3008581796-2023-00001
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    July 10, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.
    Product Code
    JAK
    PMA / PMN Number
    K171850
    Removal / Correction Number
    Z-0292/0294-202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT STATED AFTER UPGRADE TO SP2, WHEN CUSTOMER CONDUCTED PHANTOM TEST AND PERFORMED AN OFFLINE RECONSTRUCTION FOR THE EXISTING RAW DATA AND THEN COMPARED THE IMAGE IN THE 3RD PARTY TPS (THERAPY PLANNING SOLUTION) SOFTWARE, CUSTOMER NOTICED THAT THERE WAS A CROSSLINE SHIFT IN THE TPS. CUSTOMER CHECKED AND FOUND THERE¿S NO SHIFT IN CT VIEWER(A VIEWER SOFTWARE INTEGRATED INTO CONSOLE SOFTWARE TO LOAD IMAGES AND VIEW THEM). AFTER THE ISSUE REPORTED, CUSTOMER WAS ASKED TO ROLL BACK TO PREVIOUS SW VERSION. TECHNICAL INVESTIGATION INDICATES THAT THE POSITION VECTOR OF IMAGE POSITION (PATIENT) TAG (0020,0032) WAS WRONGLY CALCULATED IN THE CT CONSOLE SOFTWARE. AS A RESULT, THE POSITION TAG OF GENERATED DIGITAL IMAGING AND COMMUNICATION IN MEDICINE (DICOM) IMAGES MAY BE INCORRECT UNDER SPECIFIC CLINICAL SCENARIOS. PROBABLE CAUSE: IMAGE POSITION TAG WAS WRONGLY CALCULATED IN THE CT CONSOLE SOFTWARE. CORRECTIVE ACTION: - CORRECTION AND REMOVAL HAS BEEN ISSUED TO UPDATE THE SOFTWARE FROM 4.8.0.10421 TO V4.8.0.10430 TO CORRECT THE ISSUE.

    Additional Manufacturer Narrative · 0

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT PR# (B)(4).

    Description of Event or Problem · 0

    THE COMPLAINT STATED AFTER UPGRADE TO SP2, WHEN CUSTOMER CONDUCTED PHANTOM TEST AND PERFORMED AN OFFLINE RECONSTRUCTION FOR THE EXISTING RAW DATA AND THEN COMPARED THE IMAGE IN THE 3RD PARTY TPS (THERAPY PLANNING SOLUTION) SOFTWARE, CUSTOMER NOTICED THAT THERE WAS A CROSSLINE SHIFT IN THE TPS. CUSTOMER CHECKED AND FOUND THERE¿S NO SHIFT IN CT VIEWER(A VIEWER SOFTWARE INTEGRATED INTO CONSOLE SOFTWARE TO LOAD IMAGES AND VIEW THEM). AFTER THE ISSUE REPORTED, CUSTOMER WAS ASKED TO ROLL BACK TO PREVIOUS SW VERSION. THERE'S NO REPORT OF INJURY OR HARM DUE TO THIS ISSUE. HOWEVER, ONCOLOGY PATIENTS WHOSE INITIAL/EARLY TREATMENT PLANS MAY BE COMPROMISED BY THE RESULTING INTERFERENCE WITH THE USER¿S ABILITY TO IDENTIFY THE IMAGE POSITION AND THE POTENTIAL MISTAKES IN PLANNING OF SUBSEQUENTIAL ONCOLOGY TREATMENT. THEREFORE, WE ARE VOLUNTARILY REPORTING THIS EVENT OUT OF ABUNDANCE OF CAUTION. PHILIPS HAS NOW COMPLETED THE INVESTIGATION OF THIS COMPLAINT.

    Description of Event or Problem · 0

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THE ISSUE REPORTED WAS THAT AFTER UPGRADE TO SP2, THERE'S A CHANGE IN POSITION (SHIFT) IN 3 DIFFERENT SOFTWARE (MIM, MONACO AND VOLUME TOOL (INHOUSE SW FOR DELINEATION)) AFTER THIS UPGRADE DUE TO A DIFFERENCE IN THE X AND Y COORDINATES. THE DIFFERENCE (X-Y) DETERMINES THE SHIFT IN BOTH DIRECTIONS. THERE'S NO REPORT OF INJURY OR HARM. HOWEVER, ONCOLOGY PATIENTS WHOSE INITIAL/EARLY TREATMENT PLANS MAY BE COMPROMISED BY THE RESULTING INTERFERENCE WITH THE USER¿S ABILITY TO IDENTIFY THE IMAGE POSITION AND THE POTENTIAL MISTAKES IN PLANNING OF SUBSEQUENTIAL ONCOLOGY TREATMENT. THEREFORE, WE ARE VOLUNTARILY REPORTING THIS EVENT OUT OF ABUNDANCE OF CAUTION. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340522 BRILLIANCE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. BRILLIANCE CT BIG BORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown