(udi) and g5 (510k) are unknown; no additional information was provided.This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Sample received consisted of one (1) product, in used conditions without its original packaging.The sample was visually inspected at a distance of 12 inches under normal lighting to received units, in order to detect any damage on the unit; it was found that the breathing bag is torn.The most probable root cause is that the production personnel did not detect and scrapped the damaged breathing bag.Action(s) taken to mitigate the reported issue(s): qalert was generated and production personnel was trained to ensure detection of any marks or damage on the breathing bags.
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