(b)(4).Section b5 was corrected to change quantity of complaint mr290 units.Method: one of the two complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand where it was pressure tested.Results:the pressure test revealed a leak at the water feedset tube and chamber dome connection on the chamber.Conclusion: we are unable to determine the cause of the reported event.However, it was likely due to the water feedset tube being pulled away from the chamber dome.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.Also, the pressure test is followed by a visual inspection of each chamber.The subject mr290v chambers 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: "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" "do not use the chamber if the seals are not intact when received, or if it has been dropped.".
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