The issue, a study that reflects an incorrect patient orientation on all images, was caused by incorrect data entry at the mr scanner.The issue (incorrect orientation on images) was caused at the scanner/imaging modality.This was not caused by a deficiency or a malfunction of the merge healthcare cadstream product.
|
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) 2019, merge technical support was contacted by a user at the facility for assistance with correcting the patient orientation, which was entered incorrectly at the mr scanner.Cadstream support advised the customer the patient orientation could not be corrected in the cadstream system.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.Reference complaint number (b)(4).
|