The issue, incorrect patient orientation on all study images, was caused by incorrect data entry at the mr scanner.This is not an issue or malfunction that was caused or contributed to by the merge cadstream medical device.The root cause is due to an error by a technician at the scanner or imaging device.There have been no reports of injury or impact to a patient as a result of this issue.No further actions are anticipated at this time.
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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 merge technical support was contacted by a user at a facility for assistance with correcting a study with incorrect patient orientation.The patient's orientation was entered incorrectly at the scanner.Cadstream is prohibited, per design, from editing or modifying image (b)(4) data, including patient orientation and laterality of image data as received from other application entities.Patient images and study results have the potential to become part of the patient's permanent record and those records have the potential to impact a patient's treatment.There is a possibility for a misdiagnosis or mistreatment that could lead to harm due to the incorrect patient orientation as displayed in cadstream.However, there is no indication that this issue as reported by the customer has resulted in any harm to a patient.Reference complaint number (b)(6).
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