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 02/14/2018 |
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).The device was requested back to livanova (b)(4) for further investigation and repair.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 a s5 gas blender system displayed an error message during procedure.There was no report of patient injury.
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Manufacturer Narrative
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The gas blender system was returned to livanova (b)(6) for further investigation and repair.During the evaluation the reported failure could not be reproduced or confirmed.The device was tested intensively without malfunctions.The device was calibrated and subsequent functional verification testing was completed without issues.
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Search Alerts/Recalls
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