BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENDED BRILLIANCE WORKSPACE (EBW)

    MDR report key: 3587641 · Received November 18, 2013

    Report

    Report Number
    1525965-2013-00403
    Event Type
    Malfunction
    Date Received
    November 18, 2013
    Report Date
    September 3, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K961464
    Removal / Correction Number
    1525965-09/29/10-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO (B)(4) OF 2007. FURTHER REVIEW OF THE REPORTED EVENT HAS DETERMINED THAT IF THIS MALFUNCTION WERE TO RECUR, IT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. PHILIPS EVALUATED THE INFO AND FOUND A DISCREPANCY IN THE RESULTS. THE FUNCTIONAL ANALYSIS TOOL, WHICH DISPLAYS POLAR MAPS DEPICTING THE RELATIVE CHANGES IN THE HEART WALL, STATES THE VALUE DISPLAYED IS A PERCENT OF INCREASE IN THE WALL THICKNESS BETWEEN THE END DIASTOLIC AND THE END SYSTOLIC STATES. THE VALUE ACTUALLY DISPLAYED IS THE DECREASE IN WALL THICKNESS FROM THE END SYSTOLIC TO THE END DIASTOLIC STATE. THE WALL THICKNESS IS CALCULATED (ES-ED) /ES 100; IT SHOULD BE (ES-ED)/ED 100. FIELD CHANGE ORDER (B)(4) RELEASED A SOFTWARE UPDATE TO CORRECT THE EQUATION; THIS WAS SUBMITTED AS C&R Z-1819-2011 (1525965-09/29/10-005-C). BASED UPON CONVERSATIONS WITH THE PHYSICIAN AT THE (B)(4), PHILIPS CLINICAL SCIENCE PHYSICIAN, AND PHILIPS CLINICAL SCIENTIST SPECIALIST, IT HAS BEEN DETERMINED THAT THERE ARE NO CLINICAL IMPLICATIONS THAT WOULD RESULT BECAUSE OF THE EQUATION AND LABEL IN QUESTION. THE THICKENING POLAR MAP OBTAINED FROM CT IMAGES IS NOT A STANDARD MEASURE WIDELY USED BY PHYSICIANS IN ESTABLISHING THE MYOCARDIAL FUNCTION. PHYSICIANS ALWAYS EXAMINE THE MUSCLE FUNCTION IN A QUALITATIVE WAY BEFORE PROVIDING DIAGNOSIS. WHEN PHYSICIANS EXAMINE THE THICKENING POLAR MAP IT IS TO EXAMINE THE DIFFERENCES BETWEEN THE MYOCARDIAL REGIONS AND NOT THE EXACT NUMBERS. THE DIFFERENCES BETWEEN THE REGIONS REMAINS CORRECT, THEREFORE IT IS UNLIKELY TO CAUSE WRONG MISDIAGNOSIS. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFO THAT WHILE GATHERING DATA FOR RESEARCH, THE CALCULATED RESULTS WERE DIFFERENT FROM THOSE CALCULATED BY THE PHILIPS EBW COMPREHENSIVE CARDIAC PACKAGE. THE CUSTOMER CONTACTED PHILIPS TO VERIFY THAT THE PROVIDED FORMULA WAS CORRECT. USING THE COMPREHENSIVE CARDIAC ANALYSIS (CCA) FEATURE, THE CUSTOMER GENERATED SHORT AXIS IMAGES OF END DIASTOLIC AND SYSTOLIC PHASES, THEN CORRECTED BOTH AXES AND CONTOURS AS NECESSARY TO THEN GENERATE AT EF (EJECTION FRACTION). ONCE THIS WAS DONE THE CUSTOMER USED THE FORMULA PROVIDED IN THE SOFTWARE TO CALCULATE THE PERCENTAGE MYOCARDIAL WALL THICKENING; THE CALCULATION IS AS FOLLOWS: = (THICKNESS ES - THICKNESS ED) / THICKNESS ED. THE CUSTOMER THEN USED THE DISPLAYED NUMBERS FROM A SPECIFIC SEGMENT AND MANUALLY ENTERED THEM INTO THIS FORMULA TO CALCULATE THE PERCENTAGE THICKENING. THE RESULTS OF THEIR MANUAL CALCULATIONS ARE DIFFERENT THAN THE RESULTS GENERATED IN THE CCA FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596486 EXTENDED BRILLIANCE WORKSPACE (EBW) JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728260

    Patients

    Seq Age Sex Outcome Treatment
    1