This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.During the visual inspection, it was found a tear on the tube.During the test, anesthesia circuits did not pass the leak test.The root cause of the reported issue was found to be manufacturing.Actions were taken to mitigate the reported issue: a corrective and preventative action has been opened to address the reported issue.Udi information is unknown.Premarket (510k) number is unknown.
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