(b)(4).Method: the complaint airvo humidifier was returned to fisher & paykel healthcare in (b)(4) for evaluation.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.The fault was traced to a faulty speaker and electrical resistance testing showed that the speaker's resistance was open circuit.A lot check revealed no other complaints of this nature for lot number 130925.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.The subject airvo was manufactured before the supplier implemented these additional checks.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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