Other, six (6) samples were received with their original lid and labelling and without their original packaging, in used conditions and with their certificate of decontamination.Samples were filled with 5cc of air in order to see if there was any functional problem; after the whole cuff inflated, the cuff was deflated and inflated 4 times, all the times the cuff inflated completely and without problems.Leak test: when sample 1 was submerged under water, a leak was detected on the inflation line, a big cut was found during the test.No leaks were found in sample 2,3,4,5 and 6.The complaint is confirmed.Then air cuff symmetry test was performed.When measured the cuffs, the percentage for the symmetry were over 33.3% that is the minimum acceptable.Based on the test, the units are within specification.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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