(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was not returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the information and photographs provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the provided photographs revealed a hole in base of chamber and contamination was also observed on the chamber.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.However based on the information provided by the customer, the cause of the degradation is due to the use of xopenex and pulmozyme in the mr290v chamber.These solutions contain sodium chloride which is highly corrosive to aluminium and cause degradation of the aluminium plate over time.The mr290v chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject mr290v chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290v vented autofeed humidification chamber state the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "use usp sterile water for inhalation or equivalent for humidification.Do not add other substances to the water.".
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