| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00462-1 |
| Product Name/Description |
AirSep Impulse Elite OCD (oxygen conserving device)
Model number: OC006-3
Serial number between 088102 and 101360 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
It has been determined that there is a weak spot in the solder joint at the pressure gauge which may cause the development of a gas leak from this area. In extreme cases, there is a small chance that the pressure gauge may suddenly fail resulting in an uncontrolled release of a small volume of high pressure oxygen accompanied by a loud "bang" sound. |
| Recall Action |
Recall |
| Recall Action Instructions |
End users are requested to notify Air Liquide Healthcare if they have an affected AirSep Impulse Elite OCD. Air Liquide Healthcare will arrange for the replacement of the unit.
Affected units can continue to be used in the interim. To minimise any adverse operation of your Impulse Elite OCD end users are requested to ensure the following steps are taken:
- listen for gas leaks emanating from the OCD. Adjust the OCD on the cylinder valve. Should the leak persist, discontinue use and contact AIR LIQUIDE Healthcare customer service.
- ensure when replacing the OCD between cylinders to minimise, where possible, standing over or placing you head in close proximity to the pressure gauge. If this is required to read the gauge, then keep the duration of this inspection as short as possible. For further details, http://www.tga.gov.au/safety/alerts-device-airsep-impulse-elite-130723.htm |
| Contact Information |
1300 360 202 - Air Liquide Healthcare Customer Service |