Summary Safety Review - Airvo 2 Humidifier - Assessing the Potential Risk of Breathing Problems Associated with Undetected, Accidental Disconnection of Nasal Cannula

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2022-01-25

Product

Airvo 2 Humidifier

Potential Safety Issue

Breathing problems because of undetected, accidental disconnection of Airvo 2 from the patient.

Key Messages

  • The Airvo 2 is a medical device that delivers high flow warmed and humidified breathing gases to patients. It is authorized to be used in hospitals and long-term care facilities to provide patients who can breathe on their own with extra help.
  • Health Canada reviewed the risk of breathing problems associated with the Airvo 2 Humidifier when there is an undetected, accidental disconnection of the tube in the patient's nose (nasal cannula).
  • This review was triggered by a fatal Canadian incident report describing an undetected nasal cannula disconnection. The purpose of the review was to assess whether the current labelling and directions for use are appropriate and if additional actions are required.
  • Health Canada's review of the available information concluded that the design of the Airvo 2 Humidifier is appropriate for its use, and its instructions for use are clear. This product is not intended for life support and patient monitoring should be performed at all times.
  • Health Canada will continue to monitor the safety of the Airvo 2 Humidifier.

Overview

Health Canada has received incident reports about the accidental disconnection of the Airvo 2 Humidifier nasal cannula from patients.

Health Canada reviewed the potential risk of breathing problems associated with the undetected, accidental disconnection of the cannula from patients, and the lack of an alarm to warn of the incident. The purpose of the review was to assess whether additional actions were required for this device.

Use in Canada

  • The Airvo 2 Series Humidifier is a medical device that has been authorized in Canada since 2012.
  • The Airvo 2 Humidifier delivers warmed and humidified respiratory gases (air and oxygen) to the nose of the patient who can breathe on their own. It is used to help the patient breathe more easily. The Airvo 2 delivers gases to the patient's nose through a tube that has 2 prongs held in place by a strap that goes around the patient's head.

Safety Review Findings

  • Health Canada reviewed information from incident reports and documentation provided by the manufacturer.
  • At the time of the review, Health Canada had received 9 incident reports (all Canadian) related to the Airvo 2 Humidifier, including 1 where the patient had died. The fatal incident involved an undetected disconnection of the cannula where no alarm sounded. Three reports mentioned the lack of an audible alarm due to a faulty speaker and electrical resistance, and 1 reported the alarm was inadequate without further information. The remaining 4 reports did not involve any aspect of the alarm system.
  • Health Canada’s review concluded that the user and technical manuals for the Airvo 2 Humidifier provide appropriate directions for use and information about alarms:
    • The manuals are very clear that the Airvo 2 Humidifier is not intended for life support and that “appropriate patient monitoring must be used at all times.”
    • The manuals indicate that the Airvo 2 Humidifier sensors can detect an unconnected heated breathing tube, a leak in the system itself, a blockage, an inadequate flow of gases, incorrect oxygen concentrations, a lack of water in the reservoir, incorrect temperatures, unsuitable conditions where the device is used, and a lack of power.
  • The device is not intended to detect a disconnection of the cannula from a patient and, therefore, does not sound an alarm when it is disconnected.

Conclusions and actions

  • Health Canada's review of the available information concluded that the design of the Airvo 2 Humidifier is appropriate for its authorized use, and that the device is not expected to detect a disconnection of the cannula from a patient.
  • The safety information available in the user and technical manuals for this device is considered appropriate and sufficient at this time.
  • Health Canada will continue to monitor safety information involving the Airvo 2 Humidifier, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should any new health risks be identified.

Additional information

The analysis that contributed to this safety review included Canadian incident reports and the instructions for use provided by the manufacturer.

For additional information, contact the Medical Devices Directorate.

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