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 event could not be confirmed as the device was not returned for analysis.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of loose connection may be attributed to multiple factors including but not limited to connector damage, bent pins and/or connector wiring failure.If information is provided in the future, a supplemental report will be issued.
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