Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Regarding the involved fiber lot, the result of the performance test (gas transfer test with bovine blood (hb: 12g/dl, 37°c)) conducted in the factory's inspection was reviewed.It was confirmed that the performance value was within the manufacturer standard and no anomaly was observed.Ifu states: measure blood gases and make necessary adjustments as follows.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.Control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow.It is likely that po2 in the blood aspirated from the thorax might have been low, thereby po2 of the blood in the circuit dropped also.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
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