Catalog Number 1407JP |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/30/2016 |
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 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.The instructions for use (ifu) and patient manual include a warning to keep spare, fully charged batteries and back up controller available at all time.The steps for exchange of batteries and controllers are outlined.A supplemental report will be submitted when the manufacturer's investigation has been completed.
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Event Description
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It was reported that during a clinic visit for controller smr upgrade, controller lcd display was found error with fading out several lcd dots.It is the original primary controller of the patient, which had been used since implant date in (b)(6) 2014.Replacement was tolerated by the patient with no effect.
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Manufacturer Narrative
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One controller was returned for evaluation; the controller was received with smr upgraded.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Analysis of the device revealed that the device met specifications; the device passed visual examination and functional testing.The reported event could not be duplicated at the bench level; there were no anomalies on the controller's display during functional testing.No failure detected.No anomalies observed on the controller's display during functional testing heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
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Search Alerts/Recalls
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