Catalog Number 1407DE |
Device Problem
Image Display Error/Artifact (1304)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/04/2016 |
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 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.
|
|
Event Description
|
It was reported by the vad coordinator that smr upgrade the controller failed the preliminary test step due to reduced readability of the controller display (display is like frosted glass).The controller was exchanged with no reported effect on the patient.No further information was provided.
|
|
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.Log file analysis was not performed since this event is related to controller's display and not a controller internal functional issue.Analysis of the device revealed that the device met specifications; the device passed visual examination and functional testing.The reported event could not be duplicated at the bench level.The display functioned without any anomalies.No failure detected, the reported event could not be 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.
|
|
Search Alerts/Recalls
|