Model Number 60-02-50 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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Event Description
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Livanova (b)(4) received a report that a s5 system displayed an error message during procedure.There was no report of patient injury.
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Manufacturer Narrative
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Initially it was reported that the issue is related to a s5 system which was incorrect.The correct device is a centrifugal pump system with tubing clamp.Control, pump speed, cardiopulmonary bypass.60-02-50, 60s08704.Pma/510k: k032213.Device manufacture date: 24.01.2011.
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Manufacturer Narrative
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The customer requested that a replacement scp control panel be provided to be installed by the user.The panel was provided and successfully installed.Subsequent functional verification testing found no further issues.The replaced device was returned to livanova usa for further investigation.The reported issue could not reproduced during visual inspection and functional testing.As the issue could not be reproduced, a root cause could not be determined and no corrective actions were identified.A review of the dhr did not identify any deviations or non-conformities relevant to the issue.
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Search Alerts/Recalls
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