Events

Alerta De Seguridad para Defibrillator, Medtronic brand, Lifepak CR Plus model, ANVISA registration no. 10339190167, manufactured between November 2004 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
    830
  • Fecha
    2006-05-09
  • 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
    Medtronic Comercial Ltda announces that the substitutions will be carried out until September of 2009, and will be carried out by Medtronic Comercial Ltda. 2006. **** Update (11/05/07): Medtronic Comercial Ltda informs that it has already closed the exchange of the affected equipment and that it only awaits the consolidation of loads and the return of some units to finish the destruction of the equipment collected.
  • Causa
    Medtronic has identified that one of the printed circuit boards (pcbas) may be contaminated with solder flux and may cause a short circuit causing equipment failure during use. two factors caused this problem: 1. the solder flux was applied incorrectly and; 2. the cleaning process used to remove the solder flux has not been done correctly. information on the action as well as the list of affected series numbers can be found at http://www.Medtronic-ers.Com/notices/cr.
  • Acción
    The manufacturer is sending a communication of this event to each Institution where they were marketed and distributed for scheduling the equipment exchange. The manufacturer is also implementing a more rigorous control process to prevent contamination in the welding flow occurring again.

Device

Defibrillator, Medtronic brand, Lifepak CR Plus model, ANVISA registration no. 10339190167, manuf...

Manufacturer

Medtronic Physio Control
  • Source
    ANVSANVISA