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 request re-mapping of 2 measurements: mitral regurgitation measurement is populating the mitral valve gradient field, and when measuring both mitral regurgitation and mitral valve gradient, the incorrect mr measurement is overwritten with the correct mv gradient measurement.Work between merge healthcare and the customer is ongoing and a supplemental report will be filed when more information becomes available.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).
|
This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 4/29/2021.After additional troubleshooting by merge healthcare technical support, the measurements in question were re-mapped and tested and confirmed to be displaying correctly.No further action is required.There were no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue.
|