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 04/21/2016 |
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.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 that during smr-upgrade preliminary test procedure con failed step 1.2: display readability is reduced (milky glass).It was exchanged with the patient tolerating it well.
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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.Analysis of the device revealed that the device met specifications; the device passed visual examination and functional testing.The reported event could not be confirmed or duplicated at the bench level; no anomalies were observed on the controller's display during bench testing.The device performed as intended.No failure detected; the reported event could not be confirmed or duplicated at the bench level.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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