Events

Recall of AVEA VENTILATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH CANADA INC..

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
    59736
  • Event Risk Class
    II
  • Event Initiated Date
    2011-10-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Affected avea ventilators can over time develop a failure where the ventilator activates a false extended hihg ppeak alarm opens the safety valve and stops ventilating. while the extended high ppeak alarm is activated by design the safety valve ops to ambienta air and allowing spontaneous breathing patients to continue breathing. despite activation of the alarm under these circumstances the paitent is not subjected to elevated airway pressures.

Device

AVEA VENTILATOR
  • Model / Serial
    Model Catalog: AVEA (Lot serial: > 100 numbers contact mfg)
  • Product Description
    CAREFUSION AVEA VENTILLATORS
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC