Events

Recall of Infinity Acute Care Monitoring System (IACS) used with Kontron C500 Cockpit Kontron C500 Cockpits with revision index 06 or higher that contain 4GB RAM Modules

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger Medical 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-00735-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-06-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00735-1
  • 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
    Dräger has learned that dräger infinity acute care systems that use the newer kontron cockpits with revision index 06 or higher that contain 4gb ram modules may not annunciate audio or visual alarms on the cockpit and central station due to high memory usage. the infinity m540 will still issue both audible and visual alarms; the alarm function is not affected at the infinity m540 and infinity central station when the cockpit is disconnected. to date, dräger are not aware of any negative patient consequences arising from this issue.
  • Action
    Dräger will be contacting users to schedule a time to rework the identified devices by removing the affected Virtium RAM Modules and replacing them with the Swissbit version. In the interim, users are to remove the C500 Cockpit from service; the Infinity Acute Care System can be used without the C500 Cockpit as the Infinity M540 will function as the primary monitoring device once the Cockpit is disconnected.

Device

Infinity Acute Care Monitoring System (IACS) used with Kontron C500 Cockpit Kontron C500 Cockpits...
  • Model / Serial
    Infinity Acute Care Monitoring System (IACS) used with Kontron C500 CockpitKontron C500 Cockpits with revision index 06 or higher that contain 4GB RAM ModulesMultiple Cockpit Serial NumbersARTG Number: 168054
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd