This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Avea Ventillator (2013-09-03)
- Starting date:
- September 3, 2013
- Posting date:
- November 25, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36849
Recalled products
A. Avea Ventillator
Reason
Avea ventilators may experience the under reporting 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 5,000 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.
Affected products
A. Avea Ventillator
Lot or serial number
More than 10 serial numbers, contact manufacturer
Model or catalog number
- AVEA
Companies
- Manufacturer
-
Carefusion
22745 Savi Ranch Parkway
Yorba Linda
92887
California
UNITED STATES