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 03/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).The involved device has been requested for return to livanova (b)(4) for further investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova (b)(4) received a report that an s5 gas blender system caused an error message to display on the s5 system during setup.There was no patient involvement.
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Manufacturer Narrative
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The device was returned to livanova (b)(4) for further investigation.During the evaluation the reported failure could not be confirmed or reproduced.The device worked according the specification.As the issue could not be reproduced or confirmed, a root cause was not identified.
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Search Alerts/Recalls
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