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 11/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).Livanova (b)(4) initiated an investigation.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 roller pump was getting a motor controller error during procedure.There was no report of patient injury.
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Manufacturer Narrative
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H.10: a livanova field service representative was dispatched to the customer's facility to investigate the device and could not reproduce the issue.However, he replaced the motor control board as precaution.The pump worked as expected and was put back in service.
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Event Description
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See initial report.
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Search Alerts/Recalls
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