Sorin group (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the s5 gas blender system displayed an error message during priming.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate.The service representative ran the unit for a half hour with no faults and was unable to reproduce the reported error.A loaner unit was provided to the customer and the faulty unit was returned to sorin group (b)(4) for further investigation.The returned unit was visually inspected and functionally tested.A test run and functional check were performed without any deviations.The noted error message could not be reproduced.The device was recalibrated, disinfected, cleaned 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 the market for trends related to this type of issue.
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