Model Number 10-80-00 |
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 07/10/2019 |
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 roller pump.The incident occurred in a (b)(6).The affected part was requested to be returned to livanova (b)(4) for a detailed investigation.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 displayed an error message.Further details are pending submission.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 reported issue could be confirmed during the investigation at the manufacturer site.The analysis of the pump read-out revealed a deviations with the shaft encoder signal.It was determined that one of the channels of the encoder did not send any signal.The root cause of the reported malfunction could be addressed to a defective shaft encoder.
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Search Alerts/Recalls
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