Model Number 10-80-00 |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Livanova (b)(4) manufactures the s5 roller pump.The event occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and upgraded the touch screen from an lcd to an led display.Subsequent functional verification testing did not identify 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.Device not returned.
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Event Description
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Livanova (b)(4) received a report that an s5 roller pump experienced a graphic display failure during a procedure.There was no report of patient injury.
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Manufacturer Narrative
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The replaced processor board was returned to livanova (b)(4) for further investigation.During evaluation, the reported failure was confirmed.A faulty choke on the board was identified as the root cause for the reported issue.
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Search Alerts/Recalls
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