(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned mr290 ventented autofeed humidification chamber confirmed a long vertical crack propogating from one of the inlet ports towards the base of the chamber.A leak test was performed on the subject mr290 chamber, the results indicated that the leak rate was not within the specified range.The rolled base thickness of the chamber was found to be within specification.Conclusion: we are unable to determine the cause of the reported event.However, our investigation indicates that the most likely cause is mechanical stress.The stress source is most likely due to transportation or storage related.The mr290v chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome 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.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." - "do not use the chamber if the seals are not intact when received, or if it has been dropped.".
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