Model Number 10-85-00 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.(b)(6).Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).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 double head pump displayed a motor control error during procedure.There was no report of patient injury.
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Manufacturer Narrative
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H.10: the device was requested back to livanova deutschland for further investigation.The reported issue could be confirmed.The problem was caused by a defective resolver component.After replacement of the component no further deviations could be found and the issue could be solved.
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Event Description
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See initial report.
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Search Alerts/Recalls
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