Model Number 25-40-45 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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Event Description
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Livanova (b)(4) received a report that a s5 gas blender system displayed an error message during a procedure.The user was able to complete the procedure without incident.There was no report of patient injury.
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Manufacturer Narrative
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The gas blender was returned to livanova (b)(4) for further investigation.During the evaluation the reported issue could not be reproduced.The device worked according the specification.As the issue could not be reproduced or confirmed, a root cause was not identified.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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Event Description
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See initial report.
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Search Alerts/Recalls
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