Model Number 25-40-00 |
Device Problem
Gas Output Problem (1266)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s3 gas blender system.The incident occurred in (b)(6).Through follow-up communication livanova (b)(4) learned that user swapped out the complete s5 system with gas blender.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported error code.He inspected the device internally but he he could not find any defect.The affected device will be returned to livanova deutschland for further investigation.The device has been replaced with a new one.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 displayed an error code during priming.There was no patient involvement.
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Manufacturer Narrative
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H.10: livanova deutschland requested the defective gas blender for a further and dedicated investigation.Gas blender has been connected to the pressure air test setup.The error code reported by the customer could be confirmed during the performed functional test.The output voltage of the o2 flow sensor was found out of tolerance.The root cause of the reported malfunction could be traced back to a defective o2 flow sensor.
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Event Description
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See initial report.
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Search Alerts/Recalls
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