(b)(4).A conclusion code could not be chosen.The complaint was confirmed, but the root cause is unknown.The device history record of batch number (b)(4) that belongs to catalog number 870-35kit has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.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.The investigation revealed a loose connector on the expiratory side of the limb.Other remarks: 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.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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