Model Number 25-40-46 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 08/14/2018 |
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).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 procedure.Due to this failure a reduced brain saturation was caused which was recovered by using the mechanical backup gas blender.There was no report of patient injury.
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Event Description
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See initial.
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Manufacturer Narrative
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Through follow-up communication, livanova deutschland learned that the reported brain saturation reduction had no consequences to the patient.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Manufacturer Narrative
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The affected parts were returned to livanova deutschland for a detailed investigation.The investigator could reproduce the reported issue.The problem could be traced to defective mass flow controller and a measurement bridge.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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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See initial report.
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Event Description
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See initial.
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Manufacturer Narrative
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The defective device was returned to livanova deutschland for further investigation.During the evaluation the reported issue could be reproduced.The failure was traced to a defective measurement bridge and a mass flow controller.
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Search Alerts/Recalls
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