(b)(4).Method: the complaint device mr290v humidification chamber was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results: visual inspection confirmed that a hole was found on the base of the chamber.Additionally, contamination was found in the chamber dome.Conclusion: based on the information provided by the customer and our investigation of the complaint device, the cause of the degradation is likely due the presence of specific sterile dilluent containing sodium chloride.Sodium salt is highly corrosive to aluminium.The presence of this solution could cause degradation of the aluminium plate over time.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present 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.The subject chamber would have met the required specification prior to distribution.Our user instructions that accompany the mr290v vented autofeed humidification chamber states 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.".
|