Events

Recall of Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV & E-CAiOVX (used with CARESCAPE Monitors B850 and B650, Avance and Aisys Anesthesia Carestations, Engstrom Respiratory Carestation, or S/5 Anesthesia and Critical Care Monitors)

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-2014-RN-00488-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00488-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue due to gas sampling pump failure associated with the compact airway gas modules. loosening of the gas sampling pump hex screw in the module pump may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. if this issue occurs, the monitor will show an alarm note on monitor screen of either "low gas sample flow" or "check sample gas out".
  • Action
    GE Healthcare will implement a correction for the affected modules. If the monitor is showing an alarm of “Low gas sample flow” or “Check sample gas out”, users are advised to check the following before continued use: 1. Check the water trap is not full or occluded. If full or occluded, empty/change the water trap. 2. Check gas sampling adapter at patient airway is not occluded. 3. Check sample line is not occluded. If occluded, change new gas sampling line. 4. Check gas exhaust outlet is not occluded. Ensure there is no blockage preventing the sample gas out flow to scavenging. If the above actions do not remove the alarm message(s), it may be due to the issue described above. Users are advised to remove the equipment from use and contact technical support or local service representative. This action has been closed-out on 02/02/2016.

Device

Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV & E-CAiOVX (used with CARESCAPE Monit...
  • Model / Serial
    Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV & E-CAiOVX (used with CARESCAPE Monitors B850 and B650, Avance and Aisys Anesthesia Carestations, Engstrom Respiratory Carestation, or S/5 Anesthesia and Critical Care Monitors)Affected serial number range # 6704120 - 6778756ARTG Number: 166230
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd