Cadstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (mri) studies.Cadstream supports evaluation of dynamic mr data acquired during contrast administration.Cadstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3d renderings, and reformats).On (b)(6) 2020, a customer contacted merge healthcare to request assistance with re-processing images that were believed to be processed incorrectly.Support reviewed the incoming images and system remotely.Support found that the studies were processed as expected; however, it was noted that the images appeared to be scanned with incorrect patient orientation.The customer confirmed the images were scanned supine instead of prone so all of the images were upside down.Cadstream does not allow for the editing or modification of the original image.The customer has the ability to make annotations regarding the orientation, however, cadstream will continue to reflect the orientation as originally scanned on the processed images.Support instructed the customer regarding these images and orientation.The incorrect orientation is not a malfunction of the cadstream device nor is it a failure of the device to meet specification.The issue is use error caused originating at the mri scanner due to improper data entry.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 (b)(4).
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