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 when using the measurement tool to measure right ventricle tape, in m-mode that the decimal place is shifted causing the measurement to look incorrect in the report and workstation.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 5/5/2021.After additional troubleshooting by merge healthcare technical support, the measurement in question was re-mapped and tested and confirmed to be displaying correctly.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: 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.
|