This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Product event summary: the controller was not returned for evaluation.The reported "loose power port" event could not be confirmed as the device was not returned for analysis.Log file analysis was not performed since log files were not available for analysis; therefore the "loss of power" event could not be confirmed.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of loose power port connectors may be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.Based on the historical review of similar events, events involving loss of power may be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.If information is provided in the future, a supplemental report will be issued.
|