(b)(4).The airvo is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.The complaint airvo humidifiers are not expected to be returned to fisher & paykel healthcare (fph) (b)(4) for evaluation.There was no actual defect alleged and the hospital continues to use the subject airvos.Our investigation is based on the description of events and our knowledge of the product.Condensate in the humidification system, although not preferred, is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by multiple setup and environmental factors.Following this incident an fph representative visited the hospital in order to provide additional training and guidance on condensate management.Our user instructions that accompany the airvo humidifier provide the following guidelines: do not use the unit when the room temperature exceeds 30 degc (86 degf) or is below 10 degc (50 degf) as the unit may switch off.Humidity output will be compromised below 18 degc (64 degf) and above 28 degc (82 degf).If excess condensation accumulates in the heated breathing tube, drain by lifting the patient end of the tube, allowing the condensate to run into the water chamber.The 900pt501 breathing circuit is expected to function correctly if the user instructions are followed correctly.It is possible that the user instructions for the 900pt501 were not followed correctly.The user instructions state the following: drain condensate from the heated limb and interface periodically.Do not place the airvo humidifier in a position that is higher than the patient.
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