Events

Alerta De Seguridad para 1) Bed, Electric, Height Adjustable; (2) Mattress Adjuster; (3) Pillow Angle; (4) Adjustable Beds

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿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
    369
  • Fecha
    2001-12-03
  • 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 uk medical devices agency (mda) has issued a safety alert following the receipt of an announcement from a child who was arrested by raising and lowering the electric bed. mda states that the child was trapped under the bed while playing, unattended, with the equipment being lowered. mda also states that the electric bed and related equipment, such as mattress adjuster, pillow angle, bed adjuster, has mechanical movements and may present similar risks if children crawl or crawl underneath them.
  • Acción
    MDA recommends the following: (1) All persons involved in the sale and distribution of the above equipment, as well as the team responsible for patients or customers using these devices, should alert all users, including private users and risk of being trapped / trapped for children. (2) The risk assessment of this equipment should be made when deciding where to use it to identify all potential hazards. (3) Appropriate safety measures must be reported, including the manufacturer's instructions for use; ensuring that children are properly supervised when approaching this equipment; not allowing children to play with the equipment or its controls; when not in use, disconnecting the electric power; warning visitors and especially relatives of the potential danger of imprisonment; and ensuring that children are aware of potential hazards. ANVISA has provided the Forms of Notifications of Occurrences on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory

Device

1) Bed, Electric, Height Adjustable; (2) Mattress Adjuster; (3) Pillow Angle; (4) Adjustable Beds
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA