Model Number 25-40-45 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/22/2016 |
Event Type
No Answer Provided
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Manufacturer Narrative
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There was no patient involvement.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).Sorin group (b)(4) received a report that the s5 gas blender system displayed an error code during priming.There was no patient involvement.The device has been requested for return to sorin group (b)(4) for investigation.A follow-up report will be sent when the investigation is complete.
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Event Description
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Sorin group (b)(4) received a report that the s5 gas blender system displayed an error code during priming.There was no patient involvement.
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Manufacturer Narrative
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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 complained gas blender was requested for return to sorin group (b)(4) for investigation.However, a sorin group field service representative was dispatched to the facility to investigate and was unable to reproduce the issue.The unit was tested with a flow/oxy meter and the service representative did not identify any deviations.All results were within specification and the device worked properly.As the device was found to be in working condition, the device was not returned to sorin group (b)(4).A root cause could not be determined and corrective actions were not identified.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 trens related to this type of issue.Evaluated on site by sorin service rep.
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Search Alerts/Recalls
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