Airsep Impulse Elite Oxygen Conserving Device 의 리콜

Recall

RC-2017-RN-01448-1

Class II

2017-12-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01448-1

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.

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.