(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 provided by the customer and our knowledge of the product.Results: the customer reported that a mr290v vented autofeed humidification chamber was found cracked and leaking water during patient use.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber 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."."ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient."."perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient."."use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions could lead to a loss of ventilation pressure.".
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