(b)(4).Method: the subject mr290v vented autofeed humidification chamber was not returned to fisher & paykel healthcare for evaluation.Additionally, no further information was provided on the exact location of the reported leak.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that a mr290v vented autofeed humidification chamber provided with a rt266 infant dual heated evaqua2 breathing circuit kit was found leaking water prior to patient use.Conclusion: without the complaint device nor photographs, we are unable to determine the cause of the reported water leak.Every mr290 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.The 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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