(b)(4).\ pma/510(k): the rt021 catheter mount is sold in the usa but has no 510(k) number as it is considered a class i device.Manufacturer narrative method: the complaint rt021 catheter mounts were not returned to fisher & paykel healthcare in (b)(4) for investigation.Our analysis is accordingly based on the photos provided by the healthcare facility, and the results of previous investigations on similar complaints.Results: the photos provided by the healthcare facility revealed that the tubing cuffs were split at the connector end.Conclusion: based on our previous investigations on similar complaints, it was determined that the splitting may have occurred due to the inherent residual stress present on the extruded tube, which is a sourced component from an external supplier.We have since informed the supplier about the residual stress present on the extruded tube.We also made some improvements to our assembly process in order to mitigate the problem.All rt021 catheter mounts are pressure tested prior to release for distribution.Any catheter mount with a split tube would have failed the pressure test and be rejected from the production line.Our user instructions that accompany the rt021 catheter mount state the following: - "check all connections are tight before use." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".
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