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
    136025
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-22
  • 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 may experience the underreporting of tidal volume if used in conjunction with the neonatal hotwire flow sensor carefusion part number 16465. this error is due to the barometric pressure sensor compensation. clinically significant changes in barometric pressure are generally seen at altitudes greater than 5000 feet above sea level (asl). single patient use varflex sensors are not affected by this corrective action and will compensate for changes to atmospheric barometric pressure. the adult and pediatric patient setting are not affected by this issue.

Device

AVEA VENTILATOR
  • Model / Serial
    Model Catalog: AVEA (Lot serial: manufacturer.); Model Catalog: AVEA (Lot serial: >10 serial numbers. Contact)
  • Product Description
    AVEA Ventillator
  • Manufacturer
    CAREFUSION

Manufacturer

CAREFUSION