Catalog Number 1407DE |
Device Problem
Image Display Error/Artifact (1304)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/13/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported that some symbols became blank on the screen of the controller.Difficult to read information.(missing symbols on the screen) the controller was exchanged and the patient was stable post event.
|
|
Manufacturer Narrative
|
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.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.The reported event was confirmed via functional testing.Analysis of the device revealed that the device failed to meet specifications; the device passed visual examination but failed functional testing due to the controller's display was detected as faulty.The most likely root cause of the reported event may be attributed to a faulty display.The manufacturer has opened an internal investigation with the supplier to evaluate the defective lcd displays.Heartware will submit a supplemental report when new facts arise which materially alter information submitted in a previous mdr report.
|
|
Search Alerts/Recalls
|