(b)(4).The mr340 is a reusable chamber for heating and humidifying respiratory gases for pediatric and neonatal patients requiring respiratory support.It is intended for use with fisher & paykel healthcare mr850 humidifiers in hospital or clinical environments and should only be prescribed by a physician.Addition of heat and humidity to the supply of cold and dry respiratory gases provided through ventilation is beneficial to prevent drying of the patient's airways.Method: the mr340e reusable humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation where it was visually inspected and analyzed.Results: visual inspection of returned device revealed no damage was observed on the chamber, o-ring and base.Further inspection revealed an uneven chamfered base flange was observed and the circumference of base flange warped into an oval shape.Water leaking was confirmed when the returned chamber was connected to the water source.The base flange outer and inner diameter measurements that were taken at cross section of leaking site was found to be out specification.Conclusion: the chamber dome leaking is most likely due to chamber being warped into an oval shape and base flange outer and inner diameter being out of specification during moulding process.The side that has largest diameter has caused the o-ring to not seal properly and thus creating a gap between the wall of chamber and created a leak.Based on the provided lot details, the complaint device was manufactured by our old supplier.We have since changed to a different supplier.All mr340e chambers are visually inspected before leaving the production line and those that fail are rejected.Our user instructions that accompany the mr340e reusable humidification chamber state the following: - "ensure the mr340 o-ring is not twisted when inserted into the chamber base groove and that the chamber dome is pushed fully onto the chamber base as per the chamber assembly instructions." - "visually inspect products before each use on a patient.Discard if faulty or if there is any sign of deterioration such as cracks, tears, damage.These may cause gas leaks and loss of ventilation or respiratory support.".
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