Events

Alerta De Seguridad para Affinity® Four Birthing Bed

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

¿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
    2012-05-07
  • Fecha de publicación del evento
    2012-05-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120507.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: hill-rom affinity® four birthing bed medical device manufacturer, hill-rom, has issued a field safety notice concerning affinity® four birthing bed. hill-rom found that some of the affinity® four birthing beds, with serial number h331aa4785 through n081aa7966 produced prior to march 21, 2012, may experience problems with the brakes. the problem may result in unwanted bed movement. the manufacturer has developed an enhanced braking system for these beds and will modify the affected beds. the manufacturer also advised users to test the brake of the beds to make sure that it operates as normal until installation of the new braking system. according to the local supplier, solar-med limited, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 07 may 2012.

Device

Affinity® Four Birthing Bed
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Hill-Rom Affinity® Four Birthing Bed
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom