(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.Product background: the 900pt290e autofill chamber with adapter (900pt290e) 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.
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(b)(4).Product background: the 900pt290e autofill chamber with adapter (900pt290e) 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 900pt290e was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and videography provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Method: visual inspection of the provided videography revealed that the chamber had overfilled above the maximum water level line.Conclusion: without the return of the complaint device, we are unable to confirm the cause of the reported event.Every 900pt290e has their float functions and valves tested during the manufacturing process.Any chamber that fails this inspection is rejected.The subject chamber would have met the required specification at the time of production.The user instructions which accompany the 900pt290e as part of the 900pt561 heated breathing tube and chamber kit show in pictorial format the correct water level for the 900pt290e.The 900pt561 heated breathing tube and chamber kit also state the following: "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." "do not use the chamber if it has been dropped or been allowed to run dry as this could lead to over-filling." "do not use the chamber if the water level rises above the maximum water level line as this may lead to water entering the patient's airway." "avoid contact with chemicals, cleaning agents, or hand sanitizers.".
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