BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBW NM APPLICATION SUITE

    MDR report key: 1900587 · Received October 29, 2010

    Report

    Report Number
    2916556-2010-00020
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Report Date
    September 30, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K080961
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE IS THE ZOOM FACTOR USED BY THE TRANSMISSION RECONSTRUCTION ENGINE IS INCORRECT. THE TRANSMISSION RECONSTRUCTION ENGINE DOES NOT APPLY THE ACQUISITION ZOOM FACTOR STORED IN THE DICOM HEADER. INSTEAD, THE ZOOM FACTOR SPECIFIED IN THE "EMISSION FILTERED BACK PROJECTION (FBP) RECONSTRUCTION PAGE" IS PASSED TO THE TRANSMISSION RECONSTRUCTION ENGINE. SINCE THE EMISSION FBP DEFAULTED VALUE IS 1.0, IT IS ALWAYS PASSED TO THE TRANSMISSION RECONSTRUCTION. THIS MAY NOT BE THE VALUE STORED IN THE DICOM HEADER FOR THE TRANSMISSION DATA. IF THE ZOOM FACTOR STORED IN THE DICOM HEADER FOR THE TRANSMISSION DATA IS NOT 1.0, THEN THE TRANSMISSION RECONSTRUCTION WILL BE INCORRECT AND COULD LEAD TO A FALSE NEGATIVE DIAGNOSIS. (B)(4).

    Description of Event or Problem · 1

    VANTAGE ATTENUATION CORRECTION DATA EXPORTED TO AN EBW NM AND RECONSTRUCTED WITH THE AUTOSPECT PRO APPLICATION INCORRECTLY APPLIES THE ATTENUATION MAP CAUSING ARTIFACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBW NM APPLICATION SUITE IMAGE PROCESSING STATION KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 453560476911

    Patients

    Seq Age Sex Outcome Treatment
    1