Model Number 10-85-00 |
Device Problems
No Display/Image (1183); Image Display Error/Artifact (1304)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A distributor engineer replaced an internal board to resolve the issue.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.Device not returned.
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Event Description
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Livanova (b)(4) received a report that an s5 double head pump showed a graphical display error during a procedure.The touch screen reportedly did not function.There was no report of patient injury.
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Manufacturer Narrative
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The replaced board was returned to livanova (b)(4) for further investigation.During evaluation, the reported failure was confirmed and the root cause was determined to be a faulty inductor could be identified.The board was scrapped.
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Search Alerts/Recalls
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