Model Number 25-40-45 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Date of event is unknown.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the s5 gas blender.The incident occurred in barcelona(b)(6).The device was returned to livanova (b)(4) for further 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 message during maintenance.There was no patient involvement.
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Manufacturer Narrative
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During the investigation the reported failure could be confirmed.A deviation of the oxygen flow was detected and as root cause a defective mass flow controller could be identified.The defective part was replaced to resolve the reported issue.Subsequent functional verification testing and a calibration was completed without further issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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Search Alerts/Recalls
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