(b)(4).Method: the complaint device was not available to be returned for investigation.Therefore, our investigation is based on the information provided by the hospital, previous investigations of similar complaints and our knowledge of the product.Results: the healthcare facility reported that the inspiratory and expiratory limbs did not fit very well on to the swivel.A lot check could not be carried out as the lot information was not provided.Conclusion: without the return of the complaint device we are unable to determine what may have caused the problem reported by the customer.If the complaint device was returned it would have been visually inspected and the dimensions of the swivel would have been checked against the specification.All rt235 infant dual-heated evaqua breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt235 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.
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