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 Date 05/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova deutschland manufactures the s5 gas blender system.The incident occurred in (b)(6).The involved gas blender has been returned to livanova deutschland for 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 deutschland received a report that an s5 gas blender system displayed an error message and audibly alarmed multiple times during in-service.There was no patient involvement.
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Manufacturer Narrative
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The s5 gas blender system was returned to livanova (b)(4) for further investigation.During the evaluation a defective front panel could be determined as root cause of the reported issue.The front panel was replaced and a new calibration was performed to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to the customer.
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Search Alerts/Recalls
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