(b)(4).Evaluation conclusion: the complaint was confirmed, but the root cause is unknown.Upon receipt the circuit was visually examined for any signs of damage, abuse/misuse.It was noted that the connector on the expiratory side of the limb, which attaches to the filter of the ventilator was loose and easily removed.The complaint has been confirmed.Functional inspection - when the connector was pushed firmly back onto the circuit tubing it stayed in place and would not detach without using a significant amount of pulling force.A device history record review could not be conducted since the lot number was not provided.The investigation revealed a loose connector on the expiratory side of the limb.Root cause cannot be determined.There are several speculative scenarios that should be mentioned regarding this complaint.First, the complaint description states that the connectors became unglued.These connectors are not glued.They are press fitted onto the circuit with an alcohol lubricant/sealant.Other remarks: secondly, this connector is handled more frequently than the other connectors because it is attached to the ventilator filter which is changed daily.This end of the expiratory limb must be detached in order to change the ventilator filter which requires more opportunities for this connector to be handled and work loose.No further action required.
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