Events

Recall of Infinity Acute Care System (IACS) Monitoring Solution (Patient monitoring system) Software versions VG2.03 and higher are affected

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-2013-RN-01162-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01162-1
  • 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
    The manufacturer has found that if a low spo2 yellow medium grade alarm is displayed and paused by the user, the iacs did not generate the spo2 (red) high grade life threatening spo2 low alarm on the cockpit and the central station; only the patient monitor (m540) showed the red signal. the correct spo2 value is indicated on all devices. this iacs behaviour happens only in the neonatal mode.
  • Action
    Draeger Medical is recommending users not to pause the medium grade SpO2 low alarm without adequate patient surveillance. A software update is being developed as a permanent fix and should be available in March 2014.

Device

Infinity Acute Care System (IACS) Monitoring Solution (Patient monitoring system) Software versio...
  • Model / Serial
    Infinity Acute Care System (IACS) Monitoring Solution (Patient monitoring system)Software versions VG2.03 and higher are affectedMultiple serial numbers affectedARTG Number: 168054
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd