Events

Recall of AirSep Impulse Elite OCD (oxygen conserving device)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Air Liquide Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00462-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00462-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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

Device

AirSep Impulse Elite OCD (oxygen conserving device)
  • Model / Serial
    AirSep Impulse Elite OCD (oxygen conserving device)Model number: OC006-3Serial number between 088102 and 101360
  • Manufacturer
    Air Liquide Healthcare Pty Ltd

Manufacturer

Air Liquide Healthcare Pty Ltd