(b)(4).Method: the complaint (b)(4) airvo 2 humidifier was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the customer has stated that the (b)(4) airvo 2 humidifier did not have an audible alarm.Previous investigations into audio alarm failures 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.Conclusion: as part of our ongoing product improvement initiatives, a new speaker unit has been sourced from a different supplier.The airvo 2 user manual states that the "airvo 2 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 warns the user: prior to each patient use, ensure that the auditory alarm signal is audible by conducting the alarm system functionality check described in the alarms section the alarm system functionality check instructs the user on how to check the alarm and states that "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.".
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