Analysis: the oasis chest drain was not returned.A review of the device history records indicates that this production lot of oasis chest drains passed all quality and performance requirements.Multiple attempts to obtain more detailed information from the physician were requested.No responses from the physician were received.As stated in the instruction for use (ifu): ¿manual high negativity vent: to lower the height of the water seal column and to lower chest drain vacuum pressure when connected to suction, depress the high negativity vent located on top of the drain until the water seal column lowers to the desired level.¿ if this step was conducted the ball at the top of the water seal column would had dropped.Conclusion: based on the results of the investigation atrium medical corporation cannot conclude that the oasis chest drain was faulty.It is possible that the pressure within the drain was not relieved when the pressure regulator was adjusted.
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