A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The sensor interface board and flow sensor harness were replaced to resolve the reported issue.No report of patient involvement.On (b)(6) 2019 (b)(6):this mdr malfunction event was previously eligible for the voluntary malfunction summary reporting (vmsr) program.As of 9/16/2019 notification from fda, this product code is no longer eligible for vmsr.Therefore, this event is being reported as an individual mdr report.According to the notification, ge healthcare must submit individual reports within 30 calendar days of receiving the notification, therefore, this malfunction is being reported as an individual mdr report due 10/16/2019.
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