(b)(4).The complaint mr290vx vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in (b(6) where it was visually inspected and analysed.Visual inspection of the returned mr290vx chamber revealed small cracks with a starburst pattern around the hinge bracket near base flange.The multiple cracks were seen leading away from the point of impact.A horizontal crack was seen propagated from the small cracks.No whitening or stress mark was observed at the crack area.The rolled base thickness was measured and found to be within specification.We are unable to determine the root cause of the chamber crack.However, our investigation indicates that the crack is most likely due to mechanical force.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.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 mr290vx chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290vx vented autofeed humidification chamber state the following: - "do not soak, wash, or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "do not use the chamber if the seals are not intact when received, or if it has been dropped." - "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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