Model Number 10-80-00 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).Through follow-up communication with the technician in charge livanova (b)(4) learned that the motor control board on the faulty pump was replaced and all connections checked but no issue was found and the error message still appeared.A review of the dhr could not identify any deviations or nonconformities relevant to the 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 roller pump shown an error after switching it on during installation.There was no patient involvement.
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Manufacturer Narrative
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The affected device has been investigated at the manufacture site.A read-out analysis was performed and confirmed the reported event.After switching the pump on, the reported failure could be reproduced.A deviation could be found: the resistances of the resolver windings were out of tolerance.The root cause of the reported issue could be addressed to a defective resolver.
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Search Alerts/Recalls
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