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 08/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate and could confirm the reported issue.He replaced the shaft angle encoder with a new one and the issue was solved.Functional verification testing was completed without further issues and the unit was returned to service.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 an error message, related to the shaft angle encoder fault, was displayed on a s5 double head pump in-service.There was no report of patient injury.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: the defective encoder has been requested by livanova deutschland for a dedicated investigation.The error message could be reproduced.The shaft encoder was checked and a light diode was found to be damaged.
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Search Alerts/Recalls
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