(b)(4).Method: the complaint airvo humidifier was received at our fisher & paykel healthcare (fph) regional office in (b)(4) where it was inspected by a trained fph technician.The device was performance tested and the audible alarm function was checked.Results: during testing it was found that the visual alerts on the complaint airvo were operating, however no audible alarm was heard.Previous investigations into this type of failure have identified that the problem is caused by a faulty speaker and electrical resistance testing has shown the speaker's resistance to be open circuit.A lot check revealed no other complaints of this nature for lot number 150505.Conclusion: the supplier of the speaker unit was notified and they have carried out an investigation.The problem has been traced to an issue with the gluing process.The supplier has taken steps to ensure that each speaker is checked following the gluing process and any found faulty are discarded.Additional checks have also been implemented during production at our facility to ensure the speaker is working at the time of manufacture of the airvo.The airvo 2 user manual states that the "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases." and that "the unit is not intended for life support." the user manual also contains instructions on how to check the alarm system functionality and states that "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.".
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