Model Number 25-40-45 |
Device Problem
Output above Specifications (1432)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.(b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The device has been returned to livanova (b)(4) for investigation.A review of the dhr did not identify any deviations or non conformities relevant to the reported issue.If any additional information relevant to the reported issue 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 when the flow of the s5 gas blender system was measured during maintenance, it was found to be out of tolerance.The flow was set to 9.00 l/min and was measured as 9.37 and 9.82 l/min, which are both above the 9.30 l/min upper tolerance limit.There was no patient involvement.
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Manufacturer Narrative
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Patient information was not provided.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).The device was sent to livanova (b)(4) for investigation.A service engineer inspected the device and was able to confirm the reported issue, which due to a drift of the flow controller, thus requiring new adjustment.The device has been disinfected and cleaned and a new adjustment of the flow controller has been performed.Subsequent functional check and a test run were performed successfully.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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