Events

Recall of CareFusion - AVEA Ventilator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2015-RN-00433-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-05-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00433-1
  • 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
    When the avea ventilator develops a malfunction of the pressure transducer in the ventilator that measures the inspiratory or expiratory pressure of the circuit, a false alarm is initiated indicating an extended high ppeak or circuit occlusion depending on the specific failure mode within the pressure transducer. most reports of ext high ppeak or circuit occlusion alarms have been detected prior to use of the ventilator on a patient. if a malfunction occurs, a delay of initiation of ventilation may result. under these circumstances, the ventilator by design will alarm and cease ventilation. the safety valve will open allowing patients that can spontaneously breathe to do so. the reported rate of occurrence is very low with no reports of patient injury received to-date.
  • Action
    Customers are advised that they will be contacted by a Device Technologies representative to arrange for onsite remediation of the affected devices, in the interim if any AVEA ventilator unit exhibits a sustained Ext High Ppeak or Circuit Occlusion alarm followed by the opening of the Safety Valve, that cannot be cleared by powering the ventilator off and back on again, immediately remove the ventilator from service, provide alternate ventilation and contact Device Technologies Technical Support.

Device

CareFusion - AVEA Ventilator

Manufacturer

Device Technologies Australia Pty Ltd