No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.No visible damage detected.During functional test of product, cuff was observed to inflate asymmetrically outside of specifications.The root cause of the reported issue was found to be a deficiency during manufacturing process.This remediation mdr was generated under protocol (b)(4)., as a result of warning letter cms# (b)(4).
|