Events

Recall of Aisys CS2 and upgraded Aisys anaesthesia devices (with software version 10.X)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia 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-2016-RN-00339-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-03-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00339-1
  • 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
    Aisys cs2 anaesthesia devices and upgraded aisys anaesthesia devices deliver a momentary, self-correcting increase of the anaesthetic agent, affecting the inhaled and exhaled concentrations for a short time, upon either of the following setting changes:· a fresh gas setting change from 95%-25% oxygen to only air (21% oxygen).· any total flow setting change while using 21% oxygen (air only). the momentary bolus of anaesthetic agent will not occur with nitrous oxide as the carrier (balance) gas or if the oxygen concentration is set above 21% (air only). delivery of this momentary bolus of anaesthetic agent is potentially hazardous because it could lead to hypotension in certain vulnerable paediatric patients when 21% oxygen (air only) is used.
  • Action
    GE Healthcare is advising if possible, an alternative device should be used for paediatric patients until this safety issue is resolved. If 21% O2 in fresh gas is used, any adjustment to the fresh gas flow will deliver a bolus of inhaled anaesthetic agent, however the effects are short in duration. If the issue occurs, the device will automatically recover and return to steady state. Depending on your system configuration, one or both of these alarms could trigger if this issue occurs: -Clinician adjustable “Fi XXX High” alarm (XXX denotes the specific agent) -Alarm if respiratory gas monitoring is not present. GE will be providing a correction as a permanent fix. This action has been closed-out on 20/02/2017.

Device

Aisys CS2 and upgraded Aisys anaesthesia devices (with software version 10.X)

Manufacturer

GE Healthcare Australia Pty Ltd