Events

Recall of Drager Infinity Acute Care System (IACS) Monitoring Solution with software versions VG2.2 to VG6.0 and the Infinity M540 Stand-Alone Patient Monitor with software versions from VG2.2 to VG6.0

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-00154-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-03-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00154-1
  • 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 is placed in standby mode and the user simultaneously connects the infinity mcable- dual hemo or infinity mpod quad-hemo to the infinity m540 patient monitor and then proceeds to zero the invasive pressure channel, in rare cases the invasive pressure visual and audible alarms are not activated. although the invasive pressure value displayed on the infinity m540 patient monitor and on the infinity medical cockpit is accurate, the invasive pressure visual and audible alarms will stay disabled until the patient is discharged or the hemodynamic pod is disconnected and reconnected.This issue is not seen when the user puts the m540 into stand-by mode, and then connects the hemodynamic pod in a sequential manner. the actual ibp measurements, and the patient values are correctly displayed on both the m540 and cockpit at all times.
  • Action
    Drager is advising users to follow the below identified steps whenever the Hemodynamic Pod is plugged into the Infinity M540 Patient Monitor and the unit is placed in Standby. When users are ready to monitor the patient: 1. Exit Standby Mode 2. Unplug, pause for a minimum of 3 seconds and re-plug the Hemodynamic Pod 3. Continue per the normal procedure. Drager will be performing a software update as a permanent correction.

Device

Drager Infinity Acute Care System (IACS) Monitoring Solution with software versions VG2.2 to VG6....
  • Model / Serial
    Drager Infinity Acute Care System (IACS) Monitoring Solution with software versions VG2.2 to VG6.0 and the Infinity M540 Stand-Alone Patient Monitor with software versions from VG2.2 to VG6.0All models affectedARTG Numbers: 168054 and 98600
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd