Summary of investigation: actual device was available for investigation.One (1) sample was returned for evaluation p/n 101/860/075cz; the sample was received in used conditions without its original package.The returned sample was visually inspected at 12? to 16? and normal conditions of illumination.Inflation line was detached from pilot balloon was found; the complaint was confirmed.Customer reported: ?three (3) days after starting to use the product, the customer noticed the pilot balloon got detached from the product?.Based on the analysis conducted in the sample provided, inflation line detached failure mode was confirmed.Therefore, according to on pfmea (rmp 1065) the occurrence of this failure condition could be caused by: method not followed (not enough solvent at joint).The lot number provided by the customer was of a component piece and not the product itself so we completed a dhr of each lot where that component was used and no issues were found.A dhr was conducted which indicated all inspections were completed and no issues were noted during manufacture.
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