Events

Safety Alert for 1) Bed, Electric, Height Adjustable; (2) Mattress Adjuster; (3) Pillow Angle; (4) Adjustable Beds

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    369
  • Date
    2001-12-03
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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.
  • Action
    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
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA