(b)(4).Method: the complaint (b)(4) vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand where they were visually inspected and analysed.Results: visual inspection of the returned (b)(4) chamber revealed a long vertical crack line was found on chamber dome spanning from inlet port to flange near base.The defects identified on the chamber dome indicate that the product has sustained some form of impact damage since it was manufactured, for instance damages incurred during transportation.Further testing showed that the rolled base thickness was found to be within specification.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 (b)(4) 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 (b)(4) chamber would have met the required specification at the time of production.Our user instructions that accompany the (b)(4) 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 (b)(4) 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.".
|