The unit was not returned therefore the complaint could not be confirmed.As this complaint is associated with another complaint from the same facility in which the device was returned and found to be fully functional and not defective it is reasonable to suggest that this drain was functional as well as it is from the same lot of oasis chest drains.All drains are 100% leak tested during the manufacturing process and this lot of drains was found to have met all specifications.The oasis chest drainage system is indications for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also facilitates post-operative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.The instructions for use (ifu) advise to always place chest drain below the patient¿s chest in an upright position.To avoid accidental knock over, open the floor stand for secure placement on the floor or hang the system bedside with the hangers provided.The ifu also states to replace chest drain if damaged or when collection volume meets or exceeds maximum capacity.Related mdr 3011175548-2018-00558.
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