(b)(4).Method: the complaint mr290 humidification chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer.Results: the customer reported that a mr290v vented autofeed humidification chamber had melted during use.Conclusion: without the complaint device, we are unable to draw reasonable conclusions about the device failure.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks, and other causes.In addition, the pressure test is followed by a visual inspection of each chamber.Any chamber which fails either of these tests is rejected.The subject chamber would have met the required specification at the time of production.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." - "do not use beyond 14 days maximum duration of use".
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