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 5/5/15, a customer reported ((b)(4)) that two physicians from one center were working on one case at the same time, and they were not alerted that the case was opened by the other physician.This problem was identified as a potential safety issue in the event changes to the system affect the diagnosis or treatment of a patient.No known patients were harmed due to this complaint.
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