(b)(4).Method: the complaint mr370 reusable 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 and our knowledge of the product.Results: the customer reported that a mr370 reusable humidification chamber was found leaking water during patient use.Conclusion: without the complaint device, we are unable to draw any reasonable conclusions about the reported event.All mr370 chambers are visually inspected before leaving the production line and those that fail are rejected.The subject mr370 chamber would have met the required specification at the time of production.Our user instructions that accompany the mr370 reusable humidification chamber state the following: "the following solutions should be avoided as they may cause the chamber to crack: ketones, formaldehyde, chlorinated hydrocarbons, hypochlorite, inorganic acids, aromatic hydrocarbons, phenol (>5%)." "to prevent cracking, ensure that the water inlet port plug, and any other reusable components, are disconnected from the chamber before cleaning.".
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