Events

Alerte De Sécurité sur 1) Bed, Electric, Height Adjustable; (2) Mattress Adjuster; (3) Pillow Angle; (4) Adjustable Beds

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    369
  • Date
    2001-12-03
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA