Events

Alerte De Sécurité sur Encore, Chorus and Sara Plus Standing Aids

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
    2012-07-12
  • Date de publication de l'événement
    2012-07-12
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120712.html
  • 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 encore, chorus and sara plus standing aids the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device alert concerning encore, chorus and sara plus standing aids manufactured by arjohuntleigh. arjohuntleigh has recently been made aware of an unfortunate serious accident. during exercise, an encore standing and raising aid was used to support the patient to stand. the knee pad had been removed. however the support bracket holding the proactive knee pad support had not been removed as described in the instructions for use manual. this results in a vertical square section end of the metal support bracket becoming exposed. it would appear that the patient fell onto the metal bracket causing severe trauma. the manufacturer supplemented that this accident could have been avoided if the support bracket assembly had been removed with the proactive knee pad support. therefore, arjohuntleigh reminded users that the entire knee and support bracket assembly must be removed when required to do so for exercise. the manufacturer has amended the instructions for use to highlight the need to remove the bracket completely. according to the local supplier, the affected products have been distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts/ index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 july 2012.

Device

Encore, Chorus and Sara Plus Standing Aids
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: ArjoHuntleigh Encore, Chorus and Sara Plus Standing Aids
  • Manufacturer
    ArjoHuntleigh

Manufacturer

ArjoHuntleigh