Events

Alerta De Seguridad para Electric Reclining Chairs for. CHAIRS, EXAMINATION / TREATMENT [16-437]. Chairs, Disabled Patient [18-406]. Chairs, Disabled Patient, Geriatric [10-796]. Chairs, Disabled Patient, Pediatric [10-797]. Chairs, Disabled Patient, Seat-Lifting [17-975]. Chairs, Examination / Treatment, Dentistry [10-792]. Chairs, Examination / Treatment, Ophthalmology [15-723]. Chairs, Examination / Treatment, Otorhinolaryngology [10-794]. Chairs, Examination / Treatment, Pediatrics [16-169]. Chairs, Examination / Treatment, Podiatry [10-799]. Chairs, Flotation Therapy [10-795]. Chairs, Mammography [18-402]. Chairs, Patient Recovery [18-404]. Chairs, Patient Transfer [16-639]. Chairs, Patient Transfer, Stair [16-906]. Chairs, Radiography / Fluoroscopy [16-673]. Chairs, Radiography / Fluoroscopy, Head [18-400]. Chairs, Radiography / Fluoroscopy, Head / Torso [18-401],

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
    203
  • Fecha
    2000-11-03
  • 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 medical devices agency (mda) has issued a safety bulletin informing hospitals that there is a risk of children getting caught in the mechanism of electric reclining chairs.
  • Acción
    MDA states that all staff involved in providing chairs should alert users and attendants to the potential risk of a child becoming entangled and injured. MDA recommends the following: (1) Follow the manufacturer's instructions (2) Make sure that children are supervised when they are near the above-mentioned chairs. (3) Never allow children to play with chairs or controls (4) Unplug the appliance or remove the key, if any, when the chair is not in use. (5) Inform visitors and children of the potential risk of being injured by being trapped inside the chair. For more information, contact your local representative or directly with Ray Hodgkinson or Sarah Lepak at the British Healthcare Trades Association at (44-2-173) 245 8868. Inquiries to the MDA should mention reference number 20000605.011-22 and addressed to Malcolm Roe or Richard Glover by correspondence sent to Hannibal House, Elephant and Castle, London SE1 6TQ, England; (44-2-207) 972 8164 or 8245; or by fax (44-2-207) 972 8106.

Device

Electric Reclining Chairs for. CHAIRS, EXAMINATION / TREATMENT [16-437]. Chairs, Disabled Patient...
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA