(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.To perform an investigation and determine the source of alleged defect reported it is necessary to evaluate the sample involved in this complaint.Customer complaint cannot be confirmed based only on the information provided.Root cause is unknown.No corrective actions can be assigned at this time.If the sample becomes available this report will be updated with the evaluation results.
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(b)(4).One (1) ventilator tubing set, long length, product code 1613, 6 feet long was received for investigation.No visual signs of abuse/misuse/damage were noted.The 1613 ventilator tubing set, long length was placed on a calibrated leak tester.Approximately 12 inches from the distal column end is what appears to be a very clean "blade slice" on top of one of the tubing ribs.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 magnified pictures taken, the damage (cut) does not appear to have been caused by a manufacturing process.The cut is across the top of the rib.Based on historical findings, manufacturing related leaks do not appear in the form of a slices/cuts.This damage appears to have been caused during use.It should also be noted that all circuit tubing is 100% inspected and leak tested prior to release from the manufacturing facility; thus any defects would be detected.
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