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 05/09/2019 |
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).The device was requested back to livanova (b)(4) for further 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.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 setup.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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Livanova deutschland received the complained unit for investigation.During the investigation, the reported error could be reproduced and traced back to a defective component.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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