Events

Alerta De Seguridad para Ibis Comfort wheelchair

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

¿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
    2013-07-05
  • Fecha de publicación del evento
    2013-07-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130705.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: handicare ibis comfort wheelchair the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert concerning a number of ibis comfort wheelchairs, delivered between 29 january and 12 april 2013, manufactured by handicare b.V. the affected serial numbers are: rix01437, rix01439, rix01440, rix01442, rix01665, rix01682, rix01732, rix01805, rix01828, rix01847, rix01850, rix01869, rix01882, rix01931, rix01963, rix01992, rix01999, rix02068, rix02077, rix02098, rix02174, rix02236, rxps00847, rxps00873, rxps00882. handicare has discovered a potential quality issue with the tilt adjustment on a limited number of ibis comfort wheelchairs. in extreme situations, a component used in the tilt mechanism may break, which could cause the seat unit to tip backwards. according to handicare, no injuries have been reported. handicare has decided to replace all components from the affected batch as a precautionary measure. users are requested to order a replacement set and exchange the upper hinge blocks (article no.: 02010.6182) used in the tilt mechanism on all affected wheelchairs they have. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con295475 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 july 2013.

Device

Ibis Comfort wheelchair
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Handicare Ibis Comfort wheelchair
  • Manufacturer
    Nordic Capital Limited

Manufacturer

Nordic Capital Limited
  • Source
    DH