| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00433-1 |
| Product Name/Description |
CareFusion - AVEA Ventilator
All models and serial numbers
ARTG number: 157030 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
When the AVEA Ventilator develops a malfunction of the pressure transducer in the ventilator that measures the inspiratory or expiratory pressure of the circuit, a false alarm is initiated indicating an Extended High Ppeak or Circuit Occlusion depending on the specific failure mode within the pressure transducer. Most reports of Ext High Ppeak or Circuit Occlusion alarms have been detected prior to use of the ventilator on a patient. If a malfunction occurs, a delay of initiation of ventilation may result. Under these circumstances, the ventilator by design will alarm and cease ventilation. The safety valve will open allowing patients that can spontaneously breathe to do so. The reported rate of occurrence is very low with no reports of patient injury received to-date. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised that they will be contacted by a Device Technologies representative to arrange for onsite remediation of the affected devices, in the interim if any AVEA ventilator unit exhibits a sustained Ext High Ppeak or Circuit Occlusion alarm followed by the opening of the Safety Valve, that cannot be cleared by powering the ventilator off and back on again, immediately remove the ventilator from service, provide alternate ventilation and contact Device Technologies Technical Support.
This action has been closed out on 27/09/2018 |
| Contact Information |
1300 338 423 - Device Technologies Australia Pty Ltd |