Events

Alerta De Seguridad para Commercial Name: HMEF Cellulose Filter Technical Name: Electrostatic Filter with Heat Exchanger and Cellulose Moisture Exchanger ANVISA Registration Number: 80158680018 Hazard Class: II Model Affected: 4333 / 761PUBA Serial Number Affected: L5012678

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GVS do Brasil Ltda; GVS do Brasil 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
    2199
  • Fecha
    2016-12-20
  • 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
    When opening the primary packaging, make sure that the product is properly sealed.
  • Causa
    Upon becoming aware of the notification, gvs started the traceability of the lots and called its representative, not region - ilhatec, e-mail mr. bruno, dated 10/26/2016 - to schedule a visit to the responsible in the hospital, and if you still have pieces of the same batch reclaimed in stock for replacement, etc ... after the distributor's visit to the hospital, we had the information that it was a single part with the problem and that the rest of the lot is still used normally. in parallel, gvs had filed a complaint with the filter manufacturing supplier to initiate the cause analysis and to define corrective actions in order to avoid recurrence of the problem. on 10/27/2016, he responded to us with due treatment. they are: changing the manufacturing process and manual testing, from the filter to the automatic production line and automatic testing, avoiding operational failures.
  • Acción
    Field Action Code RNC 121/2016 triggered under the responsibility of the company GVS do Brasil Ltda. Company will make information and replacement.

Device

Commercial Name: HMEF Cellulose Filter Technical Name: Electrostatic Filter with Heat Exchanger a...

Manufacturer

GVS do Brasil Ltda; GVS do Brasil Ltda
  • Source
    ANVSANVISA