Events

Alerta De Seguridad para DEFIBRILLATOR DF-03. Registro Anvisa: 80332620005. Products affected: See list at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/953_produtos_afetados.pdf

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Transform Tecnologia de Ponta 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
    953
  • Fecha
    2009-02-03
  • 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
    The reason for product repair is related to one of the batches of the relay (electronic component) involved in the release mechanism of the equipment's electrical discharge (defibrillation). Such components may undergo premature degradation, cease to function before the programmed time and thus render the defibrillator inoperable. The manufacturer informed that it has already sent a technical newsletter to its sales representatives, informing the procedures for forwarding the products to be corrected. The Technovigilance Unit is following up on this case.
  • Causa
    One of the parts (relay) of the equipment may degrade prematurely, compromising the operation of the product.
  • Acción
    Recommended actions for product users are as follows: (1) Check if there is any equipment affected by this alert in your Health Facility; (2) If any, segregate the affected equipment (s), replacing it with equipment (s) in good conditions of use, if possible; (3) Identify the equipment (s) segregated with a poster or banner so that they are not inadvertently used; (4) Please contact the manufacturer / recorder of the product registration (Transform Tecnologia de Ponta Ltda.), Informing that you have equipment under risk in your Health Care Center. The identified products must be sent to the Technical Assitance of the factory , which will perform the exchange of components that present a risk of failure.

Device

DEFIBRILLATOR DF-03. Registro Anvisa: 80332620005. Products affected: See list at http://www.anvi...

Manufacturer

Transform Tecnologia de Ponta Ltda.