(b)(4).The fisher & paykel healthcare 900mr810 adult breathing circuits are designed for use with the mr810 humidifier in order to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases, when using a continuous or intermittent ventilator system or a continuous gas flow system.Method: the complaint 900mr810 adult heated wall reusable breathing circuit was not returned to fisher & paykel healthcare (f&p).Therefore, our investigation is based on the picture provided by the customer and our knowledge of the product.Results: visual inspection of the provided picture revealed that the tubing of the 900mr810 adult heated wall reusable breathing circuit was delaminated near chamber end cuff.Conclusion: without the complaint device, we are unable to determine the cause of the reported malfunction.All 900mr810 adult heated wall 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 900mr810 adult heated wall reusable breathing circuit state the following: "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." "do not cover the circuit with materials such as blankets, towels or bed linen." "disconnect tube by handling end connectors only, do not pull or twist tubing, as this may cause damage.".
|