Catalog Number 1407DE |
Device Problems
No Display/Image (1183); Image Display Error/Artifact (1304)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/11/2016 |
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 reference guide for both visual and tone alarms including potential causes and actions to take.Additionally there is 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.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
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Event Description
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It was reported from the site that after the smr upgrade faulty controller display was observed.An elective controller exchange was performed and it was stated that there were no effects of the patient.No additional information available.
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Manufacturer Narrative
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The controller was returned for evaluation.Analysis of the device revealed that the device failed to meet specifications; the device passed visual examination but failed functional testing due to a display error.The most likely root cause of the failure is a faulty liquid crystal display (lcd) module which most likely contributed to the event.The most likely root cause of the reported event can be attributed to a faulty liquid crystal display (lcd) module.The manufacturer has opened an investigation to evaluate the controller display error.Heartware will submit a supplemental report when new facts arise which materially alter information submitted in a previous mdr report.
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Search Alerts/Recalls
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