This mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.No problems or issues were identified during the device history record review.3 samples and 3 pictures were received.Sample 1: during the test, leaks were found in the cuff.It was observed the cuff surface was worn with areas with stretch marks.The holes were in the worn areas.The complaint is confirmed.Based on the tests performed to replicate the failure mode, where it could not be reproduced using the tools from assembly process, the most probable root cause is that damage occurred after the product left manufacturing facilities.Sample 2 and 3: when the samples were inflated with air, the cuff only inflated one side.The pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely and symmetrically, based on analysis the complaint is not confirmed.Root cause could not be determined with the provided information.No corrective actions were taken since the complaint was not confirmed.
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