Model Number 25-40-45 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/23/2018 |
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).The involved gas blender was requested for return 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.
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Event Description
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Livanova (b)(4) received a report that an s5 gas blender system delivered an unstable flow when specific settings were selected 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 affected part was returned to livanova deutschland for a detailed investigation.The investigator could not reproduce the reported issue.Since the complained issue could not be reproduced, a root cause could not be determined.
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Search Alerts/Recalls
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