There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate and was informed that the same issue occurred in the past.The affected device was requested for a detailed investigation at the manufacturer site.The pump serial read-out analysis revealed six "watch-dog" events which imply an automatic reset of the pump and thus the reported black screen.However, the affected pump was tested and the issue could not be reproduced during the investigation.Based on the investigation results and on the feedback provided to the service engineer by the customer, it cannot be ruled out that the multiple pump reboots had been caused by interferences in the operating theatre.
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