Model Number 1420 |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the controller had a bent pin in port 2.The controller was exchanged.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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The controller was not returned for evaluation.As a result, the reported event could not be confirmed.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported event can be attributed to a misalignment between the power port and battery output connector.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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