Model Number 25-40-45 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/01/2018 |
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).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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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 priming.There was no patient involvement.
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Event Description
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See initial report.
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Manufacturer Narrative
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The defective gas blender system was returned to livanova deutschland for further investigation.During the evaluation the reported issue could not be confirmed.The device worked according the specification.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
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Search Alerts/Recalls
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