Ps(b)(4).The pt101 airvo 2 humidifier device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The airvo 2 speaker is intended to provide auditory alerts to the user and auditory alarms under certain conditions.The alarm system functionality must be checked prior to each patient use.The user instructions warn "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative".In the case of speaker failures, a speaker will typically provide a distorted, intermittent or reduced sound level before becoming completely inaudible over time.This contributes to the early detection of this fault by users.It should also be noted that in the event of a speaker failure during use, the airvo 2 will continue to deliver therapy as per the set parameters.For any alarm condition, the device simultaneously displays a visual alarm alongside auditory alarms and so in the absence of an audible alarm due to speaker failure, a visual alarm will still be displayed.Method: the complaint airvo 2 was received at fisher & paykel healthcare (f&p) in new zealand.The device was performance tested and the audible alarm function was checked.Results: during testing it was found that the pt101 airvo 2 humidifier had no audible alarm.Conclusion: we are unable to determine the cause of the failure mode in this instance.
|