Model Number 60-02-50 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.Livanova deutschland manufactures the centrifugal pump system with tubing clamp.The incident 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 traced the failure to a defective display panel.The technician replaced the panel to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The panel was requested back to livanova deutschland for further investigation.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 deutschland received a report that a centrifugal pump system with tubing clamp could not be controlled as the speed knob was blocked during procedure.There was no report of patient injury.
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Event Description
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See initial.
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Manufacturer Narrative
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H.10: the reported malfunction could be reproduced.It was not possible to turn the encoder, the shaft was stuck.Moreover, the knob and other accessories of the encoder were mechanically damaged.The cause of the event has been identified in a defective shaft angle encoder.
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Search Alerts/Recalls
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