The issue, study reflects incorrect patient orientation on all 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.Cause due to an error by a technician at the scanner.No know impact to patient.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) 2018, merge technical support was contacted by a user at the facility for assistance processing a study with incorrect patient laterality, which was entered incorrectly at the mr scanner.The customer was advised the patient laterality could not be corrected in cadstream.Cadstream is prohibited from editing or modifying image dicom data, including patient orientation and laterality, received from other application entities.Study results having the potential to become part of the patients permanent record and records have the potential to impact a patient's treatment, therefore there is a possibility for a misdiagnosis or mistreatment that could lead to harm.There is no indication that this issue as reported by the customer has resulted in any harm to a patient.(b)(4).
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