Type of Product |
Medical Device |
TGA Recall Reference |
RC-2015-RN-01059-1 |
Product Name/Description |
eVent Medical Inspiration LS & i Series Ventilator Systems
Serial Number: 2009W030040
ARTG Number: 133128 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
28/10/2015 |
Responsible Entity |
|
Reason/Issue |
Investigations have identified that a component on the systems power board can fail in a manner which can cause the ventilator to shut down without the alarm being triggered. This failure could result in death or serious injury to a patient. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Users should discontinue use of the affected ventilators immediately until correction is completed. The manufacturer, eVent Medical has identified a correction to this issue which requires removal of the potentially faulty component from the power board. The corrective action will be undertaken by Taleb Medical during the month of November 2015. This action has been closed-out on 17/08/2016. |
Contact Information |
03 9330 4940 - Taleb Medical |