Events

Alerta De Seguridad para RECLINABLE ELECTRIC CHAIRS

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
    175
  • 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 united kingdom medical devices agency has delivered a safety information informing hospitals that there is the risk of children become prematured and machined in the mechanism of reclining electric chairs.
  • Acción
    MDA DECLARES THAT ALL PERSONNEL INVOLVED IN THE SUPPLY OF CHAIRS SHOULD ALERT USERS AND ATTENDEES ABOUT THE POTENTIAL RISK OF A CHILD ABUSE AND MACHINING. MDA RECOMMENDS THE FOLLOWING: (1) FOLLOW THE MANUFACTURER'S INSTRUCTIONS (2) MAKE SURE THE CHILDREN ARE SUPERVISED WHEN THEY ARE CLOSE TO THE ABOVE CHAIRS. (3) NEVER ALLOW CHILDREN TO PLAY WITH THE CHAIRS OR THE CONTROLS (4) DISCONNECT THE OUTLET OR REMOVE THE KEY, IF ANY, WHEN THE CHAIR IS NOT IN USE. (5) REPORTING VISITORS AND CHILDREN ON THE POTENTIAL RISK OF AGGRESSES. FOR FURTHER INFORMATION, CONTACT YOUR LOCAL SUPPLIER REPRESENTATIVE OR DIRECTLY WITH RAY HODGKINSON OR SARAH LEPAK AT THE BRITISH HEALTHCARE TRADES ASSOCIATION BY PHONE 44 (173) 245 8868. CONSULTATIONS TO MDA MUST MENTION REFERENCE NUMBER 20000605.011-22 E BE ADDRESSED TO MALCOLM ROE OR RICHARD GLOVER BY CORRESPONDENCE SUBMITTED TO HANNIBAL HOUSE, ELEPHANT AND CASTLE, LONDON SE1 6TQ, ENGLAND; BY PHONE (0207) 972 8164 OR 8245; OR BY FAX (0207) 972 8106

Device

RECLINABLE ELECTRIC CHAIRS
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA