As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the medical device report in accordance with our new criteria.As a result of this retrospective review, this mdr is being reported immediately upon discovery.It was reported that when taking a measurement, the system does not capture the assigned measurement at the designated image frame.The sonographer has to override it with a manual (physically choose the desired measurement) control, even then the system still does not always acknowledge the requested measurement label and defaults to a generic "d" measurement.When taking multiple measurements on the same image, the secondary requested set of measurements will default to a generic "d " measurement.Then when the sonographer goes to the next requested measurement, it is still hung up on the secondary portion of first request.If was further reported that if going out of protocol order, if sonographer opened the gb image frame and then bypass it, and then go to take the next measurement, system is still hung up on the last requested measurement (gb).When taking any volume measurements, the system always displays the "incomplete images notifications", at the end of exam, even though all requested images had been completed.The staff reported that these cause them to stop a lot, and add unnecessary time to the exams going back through to make sure they have not missed something.No additional information was provided.We are in the process of collecting patient outcome information, but due to our commitment to the fda, we are filing upon discovery of the potential adverse event before we have received patient outcome information.Unfortunately, due to the aware date, this information is not readily available and we are making every effort to obtain this information.Should we receive further information in regards to this event, we will file a follow-up report.
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