(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.Results: visual inspection of the returned mr290 chamber revealed vertical crack lines and stress marks were observed on the chamber dome.Conclusion: we are unable to determine the cause of the reported event.However, our investigation indicates that the damage was most likely due to transport damage.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 mr290 chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290hfv 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."."perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient."."ensure appropriate ventilator and flow source alarms are set before connecting breathing set to 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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