Ventilators - monitoring communication

TGA urges reporting of issues encountered in high-care settings

7 June 2017

Consumers and health professionals are advised that the TGA has received reports of problems with ventilators used in the intensive care or high-level care environment.

The TGA is aware of a range of problems involving ventilators and is interested in determining the extent of these problems and whether any pose a risk of harm to patients.

Ventilators are mechanical devices to help support breathing in patients who find it hard to breathe on their own.

To date the TGA has not received any reports of death associated with the reported problems. However, it is possible that this could have occurred if highly trained personnel were not present when incidents occurred.

Some of the problems reported are:

  • unresponsive touch screens when trying to change or check settings, particularly in alarm situations e.g., screen blank or freezing, on-screen buttons not functioning
  • spontaneous unexplained shut down
  • increased service alerts
  • auto-cycling or auto-triggering (unintended ventilation)
  • power off or on difficulties
  • oxygen sensor malfunction
  • issues related to software, interface usability, and capture of data.

The TGA is urging health professionals working in intensive or high-care environments to report any issues encountered with ventilators, to help us gain a full understanding of the extent of problems and potential consequences.

The TGA will provide further appropriate information to consumers and health professionals as it becomes available.

Reporting problems

In addition to adverse events involving ventilators, consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.