Alerta De Seguridad para External Defibrillator, Brand Medtronic, Model Lifepak 500, ANVISA register 10339190062 manufactured between February 2005 and August 2005.

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

¿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
    The Technovigilance Unit - NUVIG / ANVISA is following the actions of the company according to voluntary notification of Medtronic Comercial Ltda. Update (05/15/2006): Medtronic Comercial Ltda informs that the replacements of the equipment will be given until 01/07/2006. ************* Update: 07/20/2006 Medtronic informs that it has begun the recall of the affected products with an expiry date until 08/15/2006. ************* Update 28/08/2006 Medtronic informs the termination of the recall by replacing all notified equipment. Inquiries or clarifications contact the Representative in Brazil, Medtronic Comercial Ltda, (11) 3707-3759, Department of Regulatory Affairs or the Technovigilance Unit / ANVISA.
  • Causa
    The manufacturer has identified that an electrode component may generate an intermittent connection on the printed circuit board (pcba) blades. this component controls a number of functions which may render the device inoperative and therefore unprepared for use in an emergency. at http://www.Medtronic-ers.Com/notices/500 there is a lind for this action, as well as the list of affected series numbers.
  • Acción
    Medtronic Comercial Ltda informs that it is contacting each place where the products were distributed and a schedule will be made to exchange the device.


  • Source