Alerta De Seguridad para MONITORING AND DEFIBRILLATION SYSTEM LIFEPACK 12 - LIFEPACK 20 DEFIBRILLATOR AND LIFEPACK 9P MONITORING AND DEFIBRILLATION SYSTEM - Registered at ANVISA under the numbers 10339190080 - 10339191171 and 10339190082 - respectively. LOTS AFFECTED - according to the list attached to this Alert.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC COMERCIAL 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
  • 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
    Receipt of this information occurs because company records indicate that your organization has purchased internal paddles used in the LIFEPAK defibrillators / monitors listed above. If you no longer use these accessories, your organization is not affected. The company established a schedule of action until June / 2010 for the communication of its clients - letter attached to this Alert - July / 2010 for regularization of the petition with Anvisa and August / 2010 for the conclusion of the process. Anvisa is following this case.
  • Causa
    Physio-control, inc., a division of medtronic, inc. has updated the sterilization guide for internal defibrillator / monitor blades: lifepak®9, lifepak 9p, lifepak 12, lifepak 20 or lifepak 20e by removing ethylene oxide from the method sterilization. recommended methods are sterrad® 100s equipment and pre-vac steam.
  • Acción
    For organizations that use the internal defibrillator paddles listed above, the Sterilization Guide should be replaced for all of these accessories. We recommend that a copy of this notice be forwarded to the sterilization departments. Attached to this information is being provided the new sterilization guide (in Portuguese). The Physio-Control division is committed to ensuring that all customers are always assisted. Please contact technical support on 011-2182-9200 for any additional questions related to this action.


  • Empresa matriz del fabricante (2017)
  • 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