Model Number 25-28-67 |
Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/13/2017 |
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 defective gas blender was requested for further investigation.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 during the maintenance the measured flow of a s5 gas blender system was not correct.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.During evaluation of the returned device, the reported issue could not be reproduced.The device worked according the specification.Functional verification testing and a routine calibration were completed without issues and the unit was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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Search Alerts/Recalls
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