Weight - (b)(6) kilograms.Implanted date: device was not implanted.Explanted date: device was not explanted.510k - k130520.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The perfusion record from the involved procedure was provided and reviewed: at 10:50, the circulation started with fio2 at 60%.Pao2 at 11:08 was 36.9mmhg and was 63.0mmhg at 11:17.These indicate that pao2 was on the lower level.At 11:19, fio2 was increased from 60% to 80%.Then, at 11:24, an increase up to 148.8mmhg was noted in pao2.At 11:36, fio2 was increased from 80% to 100%.After this, there was no indication of the pao2 values in the record.A review of the device history record of the reported product code/lot number combination was conducted with no findings.Based off the information provided by the user facility, it is likely that the low fio2 caused the o2 supply volume to be insufficient, and to fail to catch up with the patient's o2 consumption volume.As the result, pao2 became lower and the correspondingly pao2 also became lower.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.Ifu states: start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements.(b)(4).
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