Events

Alerta De Seguridad para PULMONARY VENTILATOR TBIRD VELA. Registration Number with Anvisa (80071310005).

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
    870
  • Fecha
    2007-06-04
  • 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
    Slow user interface response can cause a delay in the fan alarm, which can lead to more serious problems. According to ECRI, there are 878 units of the equipment that present the problem, which were manufactured between September 15, 2006 and December 15, 2006. Distributed to several countries, including Brazil. The batches numbers of the equipments that present this problem are the following: AGT03640 up to AGT06049. #### UPDATE (11/28/2007): The company ALLIANCE S / A communicated the Anvisa Technovigilance Unit that located in Brazil a total of 156 pulmonary ventilator units model TBIRD VELA, having already carried out the software update in all these equipments. The company also sent to Anvisa's Technovigilance Unit a list of copies of the equipment upgrade records, proving the software update in the 156 units. The case report has already been filed at Anvisa's Technovigilance Unit.
  • Causa
    According to the manufacturer, the user interface device response time may become slow and, in some cases, return no response at all.
  • Acción
    The company that manufactured the product (VIASYS HEALTHCARE INC.) Has already initiated the product recall action, by letter of warning on January 31, 2007. According to the ECRI statement, users of this product will receive correction software, shipped with installation instructions. In Brazil, Anvisa's Technovigilance Unit has already contacted the holder of the product registration (ALLIANCE S / A) to verify the status of the situation in the country and awaits response to the requested information. 06/2007): ALLIANCE S / A reported that it sold in Brazil 110 equipment that falls under the "recall" alert and that since April 18, 2007, it has initiated the communication with customers who have purchased these equipments. He also informed that the conclusion for the collection action is scheduled for October 2007.

Device

PULMONARY VENTILATOR TBIRD VELA. Registration Number with Anvisa (80071310005).

Manufacturer

VIASYS HEALTHCARE INC.
  • Source
    ANVSANVISA