Model Number 25-40-45 |
Device Problem
Gas Output Problem (1266)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/26/2020 |
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).Livanova initiated an 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 a s5 gas blender system alarmed and could not oxygenate properly during priming.There was no patient involvement.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: the device was returned at the manufacturer site for investigation.The failure could not be reproduced and the device was found to be working within specifications.The device was returned back into service.Based on findings, an issue with the hospital gas supply cannot be excluded from being the root cause of the event.Since no device malfunction occurred, the reported event has been re-assessed as non reportable.
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Search Alerts/Recalls
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