Model Number 25-28-67 |
Device Problem
Gas Output Problem (1266)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/13/2020 |
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).Unit to be 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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Device checked during preventive maintenance and found that some real values are out of range.
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Manufacturer Narrative
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H.10: livanova requested the claimed unit for a detailed investigation.The reported issue was confirmed.During the calibration an error code associated to a discrepancy between actual and set values was displayed.O2 mass flow controller and o2 valve were replaced and the issue was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Customer information has been added to the dedicated e.1 section.
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Event Description
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See initial report.
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Search Alerts/Recalls
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