Events

Alerta De Seguridad para Commercial Name: VENTILATION SYSTEM - Registration: 10139810058 - Risk Class III - High Risk - Technical Name: Pressure and Volume Fan (SERIES AFFECTED SEE ANNEX).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Auto Suture do Brasil LTDA.

¿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
    1463
  • Fecha
    2014-10-20
  • 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
    Company recommends: • Replace the later Manual with this new version; • Please observe the "INOP Display (GUI)" image and the reference to Table 13-3 for recommended measurements. /// • Please review the details in Table 13-3 for information regarding loss of GUI display. • Communicate this new update within your unit as needed. • Complete the attached confirmation form and return it by e-mail to the Covidien account indicated on the form. (FORM IN ANNEX)
  • Causa
    Issue: covidien has issued this notice to customers who own the puritan bennett 840 fan to provide a recent update in the operator's manual for this fan. (letter to the customer in annex).
  • Acción
    There was the insertion of Table 1-2 in Chapter 1 and a whole new Chapter 13. These new pages provide additional instructions and information for interaction with image loss events. /// Company will perform manual update. Code: Manual Update.

Device

Commercial Name: VENTILATION SYSTEM - Registration: 10139810058 - Risk Class III - High Risk - Te...

Manufacturer

Auto Suture do Brasil LTDA
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA