Merge cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from merge.Healthcare and other vendors systems 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.Merge cardio is intended to allow users to review diagnostic and non-diagnostic quality images, annotate.Studies, perform digital subtraction on images, to perform quantitative measurements on images (including but not limited to quantitative coronary analysis, left ventricular analysis, time, area, length, velocity, angle, volume, and velocity-time integrals), to generate physician generated clinical reports (via structure reporting and template based tools), and to store this information in a database.On (b)(6) 2021, a customer contacted merge healthcare to report that a recent report was not available for viewing.Merge healthcare support found that the report was never confirmed but was in confirmed status.The logs had been truncated so they were unavailable for troubleshooting purposes.Support manually reset the status of the report and it was then able to be read and confirmed by the physician.No further action is necessary at this time.This has the potential to delay patient treatment and/or diagnosis.There have been no reports of patient injury or harm as a result of this issue.Reference complaint (b)(4).
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