Model Number 25-40-45 |
Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/30/2018 |
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).A livanova field service representative was dispatched to the facility to investigate.The service representative was unable to confirm the reported issue.The device has been requested for return to livanova deutschland 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 experienced flow fluctuations during priming.There was no patient involvement.
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Manufacturer Narrative
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The gas blender system was returned to livanova (b)(4) for further investigation.The reported malfunction could not be confirmed or reproduced during the evaluation of the device.The device worked according the specification.The devise was disinfected and cleaned.Subsequent functional verification testing was completed without issues and the unit was returned to the customer.
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Search Alerts/Recalls
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