Alerte De Sécurité sur 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par GVS do Brasil Ltda; GVS do Brasil Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2199
  • Date
    2016-12-20
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    When opening the primary packaging, make sure that the product is properly sealed.
  • Cause
    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.
  • Action
    Field Action Code RNC 121/2016 triggered under the responsibility of the company GVS do Brasil Ltda. Company will make information and replacement.

Manufacturer