Model Number 25-40-45 |
Device Problem
Gas Output Problem (1266)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/19/2020 |
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 did not identify any deviations or non-conformities relevant to the reported issue.Livanova initiated an investigation.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 a procedure and could not reach the set gas output value.The user restarted the device which worked properly again.This occurred three times thus it was decided to replaced the gas blender with another one.There was no report of patient injury.
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Manufacturer Narrative
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H.10: the affected device was requested back for investigation at the manufacturer site.The reported issue could not be confirmed and the gas blender was found to be working within specifications.Based on investigation findings, an hardware failure of device can be excluded and it cannot be ruled out that the reported event was caused by the user/hospital gas supply (i.E.Low input pressure).The event has been therefore re-assessed as not reportable.
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Event Description
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See initial report.
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Search Alerts/Recalls
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