(b)(4).Product background: the autofill chamber as part of 900pt561 heated breathing tube and chamber kit is a component designed for use with the airvo 2 humidification series to provide nasal high flow (nhf) therapy.Air and oxygen are blown from the airvo 2 into the humidification chamber within which water is heated by a heater plate.The gases become humidified in the chamber and then pass into a heated breathing tube, then to the patient interface.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint autofill chamber was not returned to fisher & paykel healthcare (f&p) for evaluation as the healthcare facility discarded the device.Our investigation is based on the information provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: the healthcare facility reported that the autofill chamber had a leak during use.The location of the leak from the autofill chamber was not specified.Further information about the reported event, including photos of the reported damage, was requested from the healthcare facility.However, no additional information was provided.Conclusion: without the return of the complaint device or any further information about the reported event, we are unable to confirm the cause of the reported event.Every autofill chamber is pressure tested following the manufacturing process to check for any leaks present in the feed set due to cracks and other causes.Any chamber that fails this inspection is rejected.The subject chamber would have met the required specification at the time of production.Our user instructions that accompany the 900pt561 heated breathing tube and chamber kit state the following: - "do not use the autofill chamber if it has been dropped or been allowed to run dry as this could lead to the chamber over-filling." - "do not use the autofill chamber if the water level rises above the maximum water level line as this may lead to water entering the patient's airway." - "for single patient use only.Reuse may result in transmission of infectious substances.Attempting to reprocess will result in degradation of materials and render the product defective." - "avoid contact with chemicals, cleaning agents, or hand sanitizers.".
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