It was reported that during an in-house study/testing using previously acquired images, it was found that the values of the vvi (velocity vector imaging) for edv (end diastolic volume) and esv (end systolic volume) for the la (left atrium) were incorrect.Accordingly, the vvi did not report the correct volumes and the differences in values were noted between two approaches in terms of the relationship between vvi la edv and la esv versus esie lh la edv and la esv.There was no patient involved during the study.No additional information was provided.
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This supplemental report is being submitted to provide the new date received by manufacturer.This issue was investigated and it was found the root cause was a software coding issue, which switched values of the numerator and the denominator.Therefore, it was a very obvious numerical error, which would not cause any misinterpretation of the values.For this complaint, when it was originally received on (b)(6) 2018, it was classified as a safety issue.Based on the information available at the time, this complaint was identified as potentially leading to misdiagnosis and therefore, it was decided to file an 803 report.However, the investigation confirmed that the switched la edv and la esv values would not be clinical viable data, and thus, would not cause or contribute to misdiagnosis of the patient, and thereby, to any patient harm.Based on these findings, this supplemental mdr is to correct the previously submitted report.Reference complaint # (b)(4).
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