Alerta De Seguridad para PULMONARY TRILOGY 100 FAN. Anvisa Record n ​​° 80102510731.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR Medical Importadora e Distribuidora de Produtos Médicos Ltda.; Philips Respironics.

¿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
    1295
  • Fecha
    2013-09-27
  • País del evento
  • Fuente del evento
    ANVISA
  • 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
    The product registration holder is sending a Safety Notice to its customers alerting the importance of meeting the preventive maintenance frequency of the Trilogy 100 Pulmonary Ventilator, as provided in the Equipment Manufacturer's Manual: preventive maintenance should be performed every two years or after 10,000 hours of use (whichever comes first) and the piece called "Blower" must be replaced preventively every 17,500 hours of use of the device. Sudden failure of the Blower during ventilation can lead to serious adverse events. The occurrence of adverse events related to the equipment must be notified to Anvisa through the NOTIVISA system, which can be accessed through the following link: http://www.anvisa.gov.br/hotsite/notivisa/index.htm.
  • Causa
    Possibility of sudden interruption of the equipment due to the stop of the piece called "blower".
  • Acción
    Users should pay attention to the frequency of execution of preventive maintenance and to the expected changeover of the mentioned part ("Blower"), as defined in the Manufacturer's Manual 1002735, version 06. The Company Safety Notice can be viewed at http: / /portal.anvisa.gov.br/wps/wcm/connect/e9f4c70041403f468ffa8fa8d08ea2d4/Aviso_de_Seanca.PDF?MOD=AJPERES