The device referenced in this report was not returned to siemens for evaluation; however, the ultrasound system savelogs were captured and reviewed.During the review, it was found that the software was not storing images due to "check-in" failures.It means that when submitting patient information identical to an existing patient, except for case differences in the patient name, a software bug will prevent the images to be stored.The image storing issue was resolved in software updates va35e (released 7 october 2015), vb10d (released 10 june 2016), and vb20a (released 17 april 2017).Reference: (b)(4).
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While preparing for an internal audit, complaints that were evaluated as part of a health risk evaluation were reviewed for alignment to the corrective actions that were taken.The complaints were filed per 21 cfr 803.In reviewing these complaints it was discovered that other complaints were missed in regards to mdr reporting.These complaints are now being submitted as mdrs.There was a fsca for all sc2000 customers in 2015 (fda # z-2783-2015).It was reported that during manual patient registration and prior to the beginning an unspecified patient exam, the ultrasound system produced an intermittent check-in failure.In addition, the ultrasound system produced a "clip cancelled" error message.There was no patient adverse event reported.No additional information was provided.
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