Alerte De Sécurité sur Alenti Lift and Hygiene Chair

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par ArjoHuntleigh.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-05-08
  • Date de publication de l'événement
    2013-05-08
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: arjohuntleigh alenti lift and hygiene chair 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.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: ArjoHuntleigh Alenti Lift and Hygiene Chair
  • Manufacturer

Manufacturer