Legal manufacturer: (b)(4).Ge healthcare was notified of this issue via user report from the (b)(6) adverse event database.The power module was replaced to resolve the reported issue.No ge healthcare service was provided.Date received by manufacturer: 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.According to the notification, ge healthcare must submit individual reports within 30 calendar days of receiving the notification.Therefore, this event is being reported as an individual mdr report due 10/16/2019.
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