Events

Recall of Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitoring Solution; and the Infinity M540 Stand-Alone Patient Monitor)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger 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-2018-RN-00265-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00265-1
  • 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
    Drager has determined that when the infinity m540 patient monitor with software versions vg4.1 and below is used in combination with the infinity mcable mainstream c02 (m11.1) revision 16 sensor, the infinity m540 patient monitor will reboot if the sensor enters a reduced accuracy mode. should the infinity m540 patient monitor reboot 3 times within a 10 minute period or less, the infinity m540 patient monitor will go into a fail-state, resulting in a resetting to factory defaults, losing patient settings and stored patient data.This issue only occurs with infinity cable revision 16. there have been no injuries reported as a result of this issue.
  • Action
    Drager is advising users to discontinue use the Infinity CO2 sensor, revision 16. Drager will be replacing all revision 16 cables with an earlier revision as an interim correction. A software update will be implemented as a long term correction.

Device

Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitorin...
  • Model / Serial
    Infinity MCable Mainstream Sensor, Revision 16 only (used with Acute Care System (IACS) Monitoring Solution; and the Infinity M540 Stand-Alone Patient Monitor) Part Number: 6871950Serial Numbers: ASKJ-0016, ASKH-0285, ASKH-0287, ASKK-0180, ASKK-0323, ASKK-0381ARTG Number: 140750Draeger Australia - Carbon dioxide sensor cable
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd