Sorin group (b)(4) received a report that the s5 gas blender alarmed and turned off during a procedure.There was no report of patient injury.The involved gas blender was returned to sorin group (b)(4) for evaluation.Testing of the returned unit, including a test run for 24 hours with various interventions was unable to reproduce the reported issue.No problems were found.A review of device history record did not find any deviations or non-conformities related to this issue.Without the ability to reproduce the reported issue, the root cause could not be determined and corrective actions could be identified.Sorin group deutschland will continue to monitor the market for trends related to this issue.
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