Events

Alerta De Seguridad para Pneumatic beds, home use, Cliniton, model CS and C-6, All serial numbers.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Hill-Rom Co Inc A Hillenbrand Industry.

¿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
  • ID del evento
    322
  • Fecha
    2001-11-02
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The electrical wires in the above beds may become hot, smoke or melt during normal operation. the manufacturer initiated a patch distributing the replacement wires and ups instructions to the home of all patients with affected beds. in addition, all service centers have received an inventory of wires to exchange current wires in their service centers.
  • Acción
    Service centers must verify that they have received Hill-Rom substitutes. Hill-Rom technicians are following the patients to see if correction procedures have been performed. If there is any affected product in your inventory that still has an affected cord or if you would like more information, contact your local representative

Device

Pneumatic beds, home use, Cliniton, model CS and C-6, All serial numbers.

Manufacturer

Hill-Rom Co Inc A Hillenbrand Industry
  • Source
    ANVSANVISA