(b)(4).To date no (b)(4) infant evaqua 2 breathing circuits have been returned to fisher & paykel healthcare (fph) in (b)(4).An investigation was conducted based on the photographs provided by an fph field representative.Visual inspection of these photographs revealed that the proximal connector collar was cracked on one expiratory limb.As no devices have been received for evaluation, a full investigation could not be completed.Therefore the cause of the observed damage could not be determined.Based on the nature of the observed cracking and previous investigations into this type of failure, this type of cracking can occur when the connectors come into contact with a cleaning chemical, resulting in environmental stress cracking.All rt265 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt265 state the following: check all connections are tight before use.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Set appropriate ventilator alarms.The user instructions also state the following: do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.
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