Events

Recall of Airsep Impulse Elite 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-2017-RN-01448-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01448-1
  • 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
    An oxygen conserving device (ocd) is subject to sudden and unpredictable failure when connected to a medical oxygen gas cylinder and pressurised. the cause of failure is due to fatigue and aging of the device as the device is now being operated outside the manufacturer's maximum recommended service life of 7yrs. failure consists of sudden localised pressure loss via the pressure gauge leading to mechanical damage. there is a small chance that this mode of failure could result in the device's outer casing breaking apart to a degree where small plastic projectiles could imact the patient depending on their proximity to the device at the time of failure. this make and model ocd (see above) was discontinued by the manufacturer (airsep) in late 2009 and no new units have been supplied to the market since that time.
  • Action
    If you own an AirSep Impulse Elite OCD complete and return the supplied Facsimile Reply Form to arrange for the renewal of your OCD. Return the form even if you no longer have an AirSep Impulse Elite OCD or previously had one but are no longer in possession of it. If you have provided any units to other users please pass this letter onto them and inform Air Liquide. If you rent an AirSep Impulse Elite OCD from AIR LIQUIDE Healthcare, we will be contacting you shortly to arrange a suitable time to recover and replace this device with a newer make and model OCD. Affected units may continue to be used until swapped out subject to the precautions described in the letter to customers.

Device

Airsep Impulse Elite Oxygen Conserving Device

Manufacturer

Air Liquide Healthcare Pty Ltd