Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, hemodynamic studies and reports, measurements (via import from dicom structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.On (b)(6) 2016, a customer contacted merge healthcare and stated that the pulmonary artery z-scores were not calculating as expected in their echo.Peds clinical report.With an incorrect value displaying in the diagnostic report, there is a potential for incorrect treatment of a patient that could result in harm.The customer indicated that there were no patients that were treated incorrectly based on the outcome of the perceived incorrect value.(b)(4).
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