Model Number 60-03-75 |
Device Problem
Device Operational Issue (2914)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump console.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The investigation is on-going.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 the touchscreen of the centrifugal pump console became unresponsive during a procedure.The device was replaced and the case was continued without further incident.There was no report of patient injury.
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Manufacturer Narrative
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A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to a defective touch screen and a defective board.Both parts were replaced to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Both parts were returned to livanova (b)(4) for further investigation.During the investigation the reported issue could be confirmed.A mechanical damage on the touch screen could be identified as root cause for the reported issue.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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Search Alerts/Recalls
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