Events

Alerta De Seguridad para External Defibrillators, Medtronic Brand, Lifepak 12 Models (ANVISA Register 10339190080) and Lifepak 20 (ANVISA Record 10339190171) manufactured between October 2005 and February 2006.

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
    827
  • Fecha
    2006-04-25
  • 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
    UTVIG / NUVIG / ANVISA has followed the actions of the company since the voluntary notification of Medtronic Comercial Ltda. More information can be obtained through the mail tecnovigilancia@anvisa.gov.br
  • Causa
    These devices contain a therapy connector that may have one or more pins that do not meet design specifications. the connector has 10 metal pins that are used as low-voltage control lines for cable connection checking, battery and power control, and transfer functions. if any of these pins have a lower depth than specified, the pin will be susceptible to excessive stress, possibly breakage, leading to a certain inoperative function. a weak connection may delay or inhibit the transport of therapy. information on the action as well as the list of affected series numbers can be found at http://www.Medtronic-ers.Com/notices/12-20.
  • Acción
    Medtronic Comercial Ltda informs that it is contacting each place where the products were distributed in order to schedule a visit to correct the affected equipment. This action will not generate any cost to the organization, simply making the equipment available at the time of inspection. Update on 06/26/2006: Medtronic Commercial Ltd. informs that all defibrillators, manufactured between October 2005 and February 2006, have been inspected and corrected.

Device

External Defibrillators, Medtronic Brand, Lifepak 12 Models (ANVISA Register 10339190080) and Lif...

Manufacturer

Medtronic Physio Control
  • Source
    ANVSANVISA