Events

Alerta De Seguridad para Encore, Chorus and Sara Plus Standing Aids

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por ArjoHuntleigh.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-07-12
  • Fecha de publicación del evento
    2012-07-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120712.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: ArjoHuntleigh Encore, Chorus and Sara Plus Standing Aids
  • Manufacturer
    ArjoHuntleigh

Manufacturer

ArjoHuntleigh