Original submission narrative: this issue is under investigation.A follow-up report will be submitted when the investigation results are available.Follow-up narrative: this supplemental report is being submitted to update the device available for evaluation , update the follow-up type , update the device evaluated by manufacturer , update the event problem and evaluation codes , and provide the investigation results.Investigation: the root cause of the device problem could not be investigated because the defective system could not be returned.Because of the device not being returned, we were unable to confirm or reproduce the issue based on the information provided.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.All original files are attached.This emdr contains both the initial and fu#1.
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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 attached 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 after a breast ultrasound procedure, the exam room smells like burning plastic after several hours of the system being turned on.There was no patient or user injury reported.No additional information was provided.
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