Other, other text: manufacturing device history record review was not performed because manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.A product sample was received for evaluation.Functional testing was performed.Functional testing performed by inflating the mask and after four (4) weeks, the mask was observed to still be inflated.No problem found, however device was most likely not inflated at the manufacturing site.This issue was addressed to the supplier so they can notify their manufacturing facility to ensure all masks are properly inflated before leaving the factory.The deflation is a common issue and it happens over a period of time as highlighted by the manufacturer.There is no scar required.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.
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