Events

Alerta De Seguridad para Avant, Avant LW and Salsa

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

¿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
    2012-03-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120309b.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
    Field safety notice: etac avant, avant lw and salsa it comes to our attention that there were 4 registered incidents involving the walker avant and 1 registered incident involving the walker salsa manufactured by etac supply center due to wheels coming off in ten year period. when delivered from etac, the wheels are mounted on each axle and fastened with a spring-loaded ring, called a lock ring. the lock ring is placed in a groove in the axle, thereby preventing the wheels coming off. when assembling or changing the wheels it is possible to open the lock ring too much, which causes a loss of its springing quality, and then cannot be fastened properly. another error may occur if the lock ring is mounted without ensuring that it fits into the groove all the way around the axle. both of these assembling errors may give the impression that the wheels are properly fastened, but such wheel can come off if it gets struck or hits an obstacle that affects the wheel sideways. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Avant, Avant LW and Salsa
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Etac Avant, Avant LW and Salsa
  • Manufacturer
    Etac Supply Center

Manufacturer

Etac Supply Center