Catalog Number 1407DE |
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 02/08/2016 |
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.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 the controller led display was faulty (loss of pixels).The controller was exchanged with no reported effect on the patient.Investigation is ongoing.
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Manufacturer Narrative
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One controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.The reported event was confirmed via visual inspection.Analysis of the device revealed that the device failed to meet specifications; the device failed visual inspection due to anomalies on the lcd display.However, after the lcd module was replaced, the controller display showed the patient information as intended.The most likely root cause of the reported event can be attributed to a faulty lcd display.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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