(b)(4).Method: the complaint 900mr810 reusable adult breathing circuit was returned to fisher & paykel healthcare in (b)(4) for evaluation.The returned breathing circuit was visually inspected, the bead width, bead height, outside diameter, film thickness and heater wire resistance were also measured.Results: visual inspection revealed a tear in the inspiratory limb near the chamber end cuff.The dryline tube was stretched.Black adhesive tape was found on chamber end cuff of the inspiratory limb and one of the cuff's on the dryline.The bead width, bead height, outside diameter, flim thickness and heater wire resistance were all within specification.There was no evidence to suggest that the returned breathing circuit was burnt.A lot check could not be carried out as the lot information was not provided by the customer.Conclusion: based on the inspection carried out the damage observed on the returned breathing circuit was most likely caused by physical damage where the circuit limb was pulled at the tube rather than the cuff.All 900mr810 reusable adult breathing circuits are visually inspected and pressure tested prior to being released for distribution.Any circuits that fail are rejected.This suggests the reported damage occurred after the subject breathing circuit was released for distribution.The user instructions that accompany the 900mr810 reusable adult breathing circuits state: "inspect circuit before re-use, do not use if the circuit shows signs of deterioration such as: cracks, tears or damage." "perform a pressure and leak test on the breathing system, and check for occlusions before connecting to a patient." "disconnect tube by handling end connectors only, do not pull or twist tubing as this may cause damage." "set appropriate ventilator alarms.".
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