Model Number 25-40-45 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).A review of the dhr could not identify any deviations or nonconformities relevant to the issue.The involved device was sent to manufacturer for investigation.The reported issue was confirmed and was traced back to a faulty power supply board.
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Event Description
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Livanova (b)(4) received a report of a s5 gas blender system shut-down during procedure.Another device was used to complete the surgery.There was no report of patient injury.
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Manufacturer Narrative
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The power supply was replaced and the issue solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
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Event Description
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See initial report.
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Search Alerts/Recalls
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