Two pictures and 2 samples was received with their original packaging and in used conditions.No damage could be detected during visual inspection.Samples were inflated with 20cc of air to see if there was any functional problem.When inflating the samples with 20cc of air, the cuff immediately deflated.When the units were submerged under water, leaks were easily detected in both cuffs.The complaint is confirmed.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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