(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.No corrective actions can be established.In order to perform a proper and thorough investigation to confirm the alleged defect, determine a root cause and establish corresponding corrective actions, it is necessary to evaluate the sample involved.If the device sample becomes available at a later date this complaint will be updated accordingly.
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Qn# (b)(4).One (1) ventilator tubing set, long length, product code 1613, 6 feet long was received for investigation.A visual exam was performed and there were no signs of abuse/misuse/damage.The 6 foot section of tubing was placed on a calibrated leak tester.Both ends of the tubing set are identical.Approximately 16 inches from one end, identified with blue pin ink from the customer, is a short series of what appears to be tears, which evolved into a puncture (hole) in the tubing.Once the tube set was submerged into a bath of water with the prescribed amount of air pressure, a profuse leak was discovered via bubbling.The leak was so profuse a leak value could not established by the leak tester.The leak rate specification is governed by iso 5367, 2014, annex e, which specifies an adult circuit under 60 +- 3 cmh2o of air pressure, cannot exceed a leak rate greater than 70 ml/min.Based on the investigation performed, the reported complaint was confirmed.The damage (hole) does not appear to have been caused by a manufacturing process.The tear/s are across the top of the ribs and then evolves into a hole (puncture).This damage appears to have been caused during use.All circuit tubing is inspected and leak tested 100% at the manufacturing facility; thus a defect such as this would be detected prior to release.
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