Model Number 25-40-45 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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 investigation and repair.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 a s5 gas blender system displayed wrong values during priming.There was no patient involvement.
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Event Description
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Livanova deutschland received a report that a s5 gas blender system displayed wrong values during priming.There was no patient involvement.
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Manufacturer Narrative
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The complained unit has been received in livanova deutschland for further investigation.A functional test has been carried out.Results revealed that the reported event could not be reproduced.The device has been opened and visually inspected.No deviation could be found.As the reported malfunction could not be confirmed, the root cause of the event could not be identified.
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Search Alerts/Recalls
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