Sorin group (b)(4) manufactures the s5 gas blender system.The incident occured in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).The gas blender was returned to sorin group (b)(4) for investigation.The reported issue was confirmed during functional testing and the issue was traced to several defective components.The mass-flow meter/controller for o2, two vs-sealing rings, two plug o-rings and the egd board were replaced and a functional check and new calibration were performed.Functional control and technical safety inspection were successfully carried out and no further issues were discovered.The device was cleaned and disinfected and returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.
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