Events

Alerta De Seguridad para Medi-Trace CADENCE - Defibrillation Electrodes - Model: 22660R - Register: 80136710169 - Risk Class I (LOTS AFFECTED ATTACHMENT)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Auto Suture do Brasil LTDA; Ludlow,a Division of tyco Healthcare Group LP.

¿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
    1439
  • Fecha
    2014-10-20
  • 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
    Company informs that Covidien's Medi-Trace CADENCE Defibrillation Electrodes with Model 22660R should not be used in Philips FR3 and FRx AED defibrillators. It directs you to review Covidien's use of Covidien's defibrillation electrodes to ensure that Covidien's electrodes are not used with Philips FR3 and FRx AEDs models. ## UPDATE 10/21/2014: Company has communicated to its customers that product will no longer be marketed by internal decision and that as of 10/16/2014 the marketing of the product is no longer authorized.
  • Causa
    Covidien's medi-trace cadence defibrillation electrodes will not connect to philips aed fr3 or frx units, and using these defibrillation pads with philips aed fr3 or frx units may result in delayed therapy. the phillips aed frx unit requires the cushions to be pre-wired and, if it is missing, a continuous sound alarm will be issued to alert the user that the proper cushions are not connected to the unit before use.
  • Acción
    Company is notifying the customer of the correct use of the product and providing a change in the instructions for use and labeling of the product (Field action type: Updating, correcting or supplementing the instructions for use) -xxx- (CUSTOMER CARD IN ANNEX - SAFETY NOTE OF URGENT FIELD) -xxx- (RECEIPT CHECK FORM IN ANNEX) - Cadence Code ## UPDATE ON 10/21/2014: Company informed that the product will be discontinued, according to LETTER IN ANNEX 33

Device

Medi-Trace CADENCE - Defibrillation Electrodes - Model: 22660R - Register: 80136710169 - Risk Cla...

Manufacturer

Auto Suture do Brasil LTDA; Ludlow,a Division of tyco Healthcare Group LP
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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
    ANVSANVISA