Other, other text: d10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Thirteen devices were received in total.Eight were received without their original packaging, one of which was received without bag and five were received with their original packaging and completely sealed.During visual inspection, it was possible to detect one device with a broken/damaged tube, which caused the leaking failure mode; the rest of the twelve devices did not have any defects.A leak test was performed on the damaged device in which there was an air leak.The complaint was confirmed by visual inspection and functional testing.The root cause was damage caused by the improper handling of the product during its assembly.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.All mitigations in place were verified and it was confirmed they have been executed accordingly, the manufacturer will continue monitoring this failure condition in this product for threshold or escalation.
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