(b)(4).The rt319 adult breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.Method: the complaint rt319 adult breathing circuit was returned to fisher & paykel healthcare (b)(4) where it was visually inspected.Results: visual inspection revealed a cut in the complaint circuit.A lot check revealed no other complaints of this nature for lot 150611.Conclusion: based on the damage observed on the returned rt319 adult breathing circuit, it is likely that the circuit was cut with a sharp object.All breathing circuits are pressure tested for leaks prior to being released for distribution.Any circuits that fail are rejected.The hospital reported that the reported damage occurred after one day of use, which suggests that the returned rt319 adult breathing circuit was damaged after it was released for distribution.The user instructions accompanied by the rt319 adult breathing circuit state: before connecting to patient, ensure that flow and pressure testing applicable to the ventilator has been completed.Set appropriate ventilator alarms.
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