Events

Recall of AVEA VENTILATOR

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

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
    134806
  • Event Risk Class
    II
  • Event Initiated Date
    2015-04-28
  • 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
    Avea ventilators can over-time develop a pressure transducer failure where the ventilator activates a false extended high ppeak or circuit occlusion alarm. this will cause safety value to immediately open and stop device from ventilating. (193 devices/154 spare parts affected).

Device

AVEA VENTILATOR
  • Model / Serial
    Model Catalog: AVEA (Lot serial: all lots)
  • Product Description
    AVEA Ventilator
  • Manufacturer
    CAREFUSION

Manufacturer

CAREFUSION