Events

Recall of Carestation 620, 650 and 650c A1 Anaesthesia devices Carestation

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-2017-RN-00640-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00640-1
  • 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 have identified 2 issues with carestation 620, 650 and 650c systems which have the potential for elevated fico2 and unexpected system malfunction.1. an incomplete seal can exist between the disposable absorber and the breathing circuit lower assembly of the carestation 600 series systems. this incomplete seal can allow rebreathing of patient gases that have bypassed the carbon dioxide (co2) absorbent material and could result in unintended elevated inspired levels of co2 (fico2), which could lead to hypercarbia.2. an unexpected transition to a system malfunction state can occur, which will display the following message on the screen: “system malfunction internal problem prevents normal operation. use backup ventilation. to restart, turn power off and on". if the system malfunction is left unresolved, it could result in loss of mechanical patient ventilation, which could lead to hypoxia. to date, there have been no injuries reported to ge as a result of these issues.
  • Action
    GE will arrange for correction of devices. In the interim, the following instructions are provided: 1. If elevated FiCO2 is observed, increasing the flow of fresh gas can reduce the volume of patient gas that could be rebreathed, consistent with standard clinical practices. If the FiCO2 cannot be adequately reduced with this action, consider switching to another anaesthesia device. Use a CO2 monitor whenever anaesthesia is delivered. 2. If unexpected transition to a System Malfunction state occurs: - Manually ventilate patient (move bag-to-vent switch to bag position, adjust APL, increase Oxygen (O2) flow as needed to fill the manual bag), - Monitor patient, - Cycle system power off then on by pressing the power switch twice 5 seconds apart to run the power up self-tests and restore normal operation. Ensure existing pre-use instructions are followed and verify that a method of back-up ventilation, independent of the anaesthesia machine, is available and functional prior to use.

Device

Carestation 620, 650 and 650c A1 Anaesthesia devices Carestation
  • Model / Serial
    Carestation 620, 650 and 650c A1 Anaesthesia devices Carestation 620 A1 GTIN: 00840682103985Carestation 650 A1 GTIN: 00840682103947Carestation 650c A1GTIN: 00840682103954ARTG Number: 93955
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd