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 05/03/2016 |
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 the controller did not pass the pre upgrade check.It was stated that the display was not readable and pump parameters were not visible.An elective controller exchange was performed and it was stated that there were no effect on the patient.No additional information available.
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Manufacturer Narrative
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The 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 of display error was confirmed via visual inspection.Analysis of the device revealed that the device failed to meet specifications; the device failed visual inspection due to a blurry and faded display overlay on the outside of the controller.The controller did not receive the smr upgrade.The original lcd display cover/ overlay was most likely related to environmental factors.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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