Important Safety Alerts

Health Canada has issued a medical device safety alert, concerning Alenti Lift and Hygiene Chair., manufactured by ArjoHuntleigh.

ArjoHuntleigh, in collaboration with Health Canada, issued the safety notice to re-iterate safety information to prevent the risk of chair tipping and patient falls with the Alenti Lift and Hygiene Chair. These incidents can be caused by operator use error and patient factors, and can lead to serious patient injury or death.

Between 2004 and 2007, ArjoHuntleigh conducted field safety correction actions to provide improved safety instructions and warnings to reduce the risk of Alenti chair tipping and patient falls. The incident rate has since declined; however, ArjoHuntleigh continues to receive several incident reports in Canada each year. To further reduce the number of incidents associated with the Alenti chair, ArjoHuntleigh would like to re-iterate the following important safety information.

• Alenti chair tipping and patient falls can occur if an operator fails to strictly follow all operating and safety instructions in the Instructions for Use.
• Alenti chair tipping and patient falls have continued to occur in Canada, some of them leading to serious patient injuries and death.
• All personnel who may be involved in operating the Alenti chair should be familiar with the risk factors that are known to cause chair tipping and patient falling incidents.

For details, please visit the following Health Canada website:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/29019a-eng.php

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 08 May 2013