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) 2020, a customer contacted merge healthcare and stated that stress data was labeled incorrectly.Merge healthcare support has been in contact with the customer multiple times since this report and is currently working on gathering further information.At this time, there are no reports of patient harm or injury due to this issue.A supplemental report will be submitted as soon as more information is available.Reference complaint (b)(4).
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This supplemental report is submitted to the fda in accord with applicable regulations and as indicated by merge healthcare in the initial report submitted 8/28//2020.After additional troubleshooting by merge healthcare technical support, the measurements in question were re-mapped and tested and confirmed to be displaying correctly.The customer was repeatedly nonresponsive and needed many follow ups to confirm.No further action is required.Revised information contained in this supplemental report includes the following: g3 - date new information received by manufacturer.G6 - indication that this is follow-up report 001.H1 - indication of malfunction as reportable event.H2 - indication of additional information.H3 - indication that device evaluated by manufacturer.H6 - evaluation codes: health effect - clinical code: 4582 no clinical symptom/sign.Health effect - impact code: 2199 no health consequences or impact.Medical device problem code: 1449 application program problem: parameter calculation error.Component code: 4755 part/component/sub-assembly term not applicable.Type of investigation: 10 testing of actual/suspected device.Investigation findings: 3200 incorrect data definition.Investigation conclusions: 143 quality control deficiency.There were no reports of death, serious injury or injuries that were directly caused or contributed to as a result of this issue.
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