(b)(4) method: the complaint 900mr810 adult evatherm reusable breathing circuit was returned to fisher & paykel healthcare in (b)(4) for inspection.The returned breathing circuit was visually inspected.The bead width, bead height, outer diameter and film thickness were also measured.Results: visual inspection revealed that the breathing circuit film was torn near the patient end cuff.The bead width, bead height, outer diameter and film thickness were all within specifications.The dry line tube was found to have been stretched.A lot check revealed no other complaints of this nature for lot number 150106.Conclusion: based on the investigation conducted, the damage observed to the returned breathing circuit was most likely caused by physical damage.It appears that the subject breathing circuit was pulled at the tube part instead of the cuff, causing the fault reported by the healthcare facility.All 900mr810 adult evatherm reusable 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 900mr801 adult evatherm reusable breathing circuit 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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