AirSep Impulse Elite oxygen conserving device
Recall - potential gas leak
23 July 2013
Consumers and health professionals are advised that Air Liquide Healthcare, in consultation with the TGA, is recalling from the market certain AirSep Impulse Elite oxygen conserving devices (OCDs) manufactured before early 2006.
AirSep Impulse Elite OCDs are used with portable cylinders to provide users medical oxygen at their prescribed dosages.
This recall affects AirSep Impulse Elite OCDs (model number OC006-3) with a serial number ranging from 088102 to 101360. The serial number can be found on the upper part of the label on the back of the device (see picture above).
It has been identified that there is a weak spot in the solder joint at the pressure gauge of affected AirSep Impulse Elite OCDs. This may lead to gas leaking from this area. There is a small chance that the pressure gauge could fail, resulting in an uncontrolled release of a small amount of high pressure oxygen, accompanied by a loud 'bang' sound.
Air Liquide Healthcare is writing to AirSep Impulse Elite OCD users to provide further information about this issue, including details of the recall procedure.
If you have an AirSep Impulse Elite OCD (model number OC006-3), check the serial number to see if it falls within the range of 088102 to 101360.
If so, follow Air Liquide Healthcare's instructions for arranging a replacement or call its customer service line on 1300 360 202 for further information.
If you are waiting for a replacement device, you can continue to use an affected AirSep Impulse Elite OCD but are advised to undertake the following steps:
- Listen for gas leaks coming from your OCD. If you hear a leak, adjust the OCD on the cylinder valve. If the leak persists, discontinue use of the device and contact Air Liquide Healthcare's customer service line on 1300 360 202 for assistance.
- Minimise any time spent standing over or placing your head close to the pressure gauge when transferring the OCD between cylinders or reading the gauge.
Please note that Air Liquide Healthcare is writing to AirSep Impulse Elite OCD users to provide further information about this issue, including details of the recall procedure (see 'Information for consumers').
If you or a patient have any questions or concerns about AirSep Impulse Elite OCDs, call Air Liquide Healthcare's customer service line on 1300 360 202.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
Content last updated: Tuesday, 23 July 2013
Web page last updated: Thursday, 25 July 2013