The device referenced in this report was not returned to siemens for evaluation; however, the system log files were captured and analyzed.During the analysis, it was confirmed that the event was a check-in failure where the patient's file was not saving correctly at the conclusion of an exam.The root cause was determined to be a software bug and the reason for failure is that the oracle database still had the original patient name information in the lookup tables even thought the exam data had been deleted.The issue was resolved in software updates (16 dec 2015), vb10d (03 jun 2016), and vb20a (17 apr 2017).(b)(4).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).
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