Events

Recall of Astral Ventilators

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Resmed Limited.

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-2015-RN-00391-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00391-1
  • 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
    Resmed received an incident report involving circuit disconnection of a patient in a hospital where the device alarms did not operate because all alarms had been disengaged by the physician and the patient required medical intervention.
  • Action
    ResMed advises that, as long as the disconnection alarm is not disabled for high-dependency patients who are using the device continuously, as directed in the Instructions for Use, the above safety concern will not occur. Alarm configurations can only be changed by health professionals and cannot be modified by the patient in the home. ResMed intends to release and install an updated version of Astral software, in three months’ time, in which the circuit disconnection alarm for all ventilation modes for dependent patients cannot be deactivated. For more details, please see https://www.tga.gov.au/alert/astral-100-and-astral-150-ventilators. This action has been closed-out on 05/09/2016.

Device

Astral Ventilators
  • Model / Serial
    Astral VentilatorsAstral 100Model No: 27081Astral 150Model No: 27083ARTG Number: 219429
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited