Alerta De Seguridad para Trade name: VIP BIRD pediatric ventilator, GOLD and STEARLING models; Registration number in Anvisa: 80071310002.

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

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Anvisa contacted the holder of the product registration in Brazil and requested clarification on the actions taken by the company. ALLIANCE S / A informed Anvisa that it has in Brazil two product units that are on the RECALL lists of the FDA. According to the company the same are used only for promotional purposes. The company also said it is awaiting replacement kits from the manufacturer, which have already been shipped by VIASYS HEALTHCARE, and will carry out the replacement as soon as the exchange material arrives in Brazil.
  • Causa
    There is a possibility that 2017 units of the vip bird models gold (gold) and stearling (silver) pediatric ventilators will fail in their operating cycles when used. the problem possibly occurs when the set flow level is too high and the air flow that goes into the equipment is greater than 15 l / min, as in some occasions with nebulizers. the presence of bacteria filters and the presence of water inside the equipment tubing are factors that can aggravate the problem. according to the manufacturer, such a problem poses no risk, since: (a) an audible alarm is triggered automatically by the equipment when the problem occurs; and (b) the number of persons assigned to the care of neonates admitted to intensive care units is generally high, which ensures a rapid response to the problem if it occurs. equipment which may present problems of this type is as follows: (a) catalog numbers 15654: products with serial no. aam01128 through abmo1015 (for domestic use only) and products with serial no. aam01119 through acmo1142 (intended for to other countries, including brazil); (b) catalog numbers 15653: products with serial number aam01001 to ammo1590 + kji01178 (for us domestic market only) and products with serial number aamo1648 to aem01298 (for other countries, including brazil).
  • Acción
    The manufacturer company (Viasys Healthcare Inc.) began a withdrawal from the market by letters dated November 2 and 4, 2006. The FDA has already initiated the call for a Class II recall (No. Z-0480 / 0481-2007) . Anvisa contacted the holder of the product registration in Brazil and requested clarification on the actions taken by the company. #### Update_21 / 09/2007: The company ALLIANCE S / A sent documentation proving the replacement of the software packages in the two equipment. The company considers the collection closed.


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