Events

Alerte De Sécurité sur EXTERNAL DEFIBRILLATORS: LIFEPAK 12 (Anvisa Reg. 10339190080); LIFEPAK 20 (Anvisa Reg. 10339190171); LIFEPAK 500 (Anvisa Reg. 10339190062); LIFEPAK 1000 (Anvisa Reg. 10339190300); LIFEPAK CR PLUS (Reg Anvisa 10339190167).

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 Physio-Control Inc.; Medtronic Comercial 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
    930
  • Date
    2008-06-30
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    The term of the permanent prohibition agreement signed on April 25, 2008 by Physio-Control Inc./Medtronic Inc. restricts the shipment of manufactured products to the Redmond, WA facility due to deficiencies in the Good Manufacturing Practices system verified in inspections performed by the FDA. According to information from ECRI and Medtronic Comercial Ltda, the shipment of products from the Redmond, WA plant to the US market has been voluntarily suspended since January 2007. With the signing of the permanent ban company is prohibited from manufacturing, distributing and exporting Automated External Defibrillators (see Product Description field) until Redmod equipment and plant are in accordance with Good Manufacturing Practices. Despite this, the company is authorized by the FDA to conduct a limited selection of products to meet critical customer needs on emergency occasions when necessary. The Anvisa Technovigilance Unit has already initiated a contact with Medtronic Comercial Ltda (holder of product registrations in Brazil). #### Update (12/03/2010): According to information presented by Medtronic Comercial Ltda, the prohibition established by the consent decree was withdrawn by the US FDA on 02/18/2010.
  • Cause
    On april 25, 2008, physio-control inc (a subsidiary of medtronic inc) has signed a consent decree with the us food and drug administration (fda), whereby the company is legally the world-wide shipment of products manufactured at the redmond, wa unit. the reason for this action was the fda's detection of problems in the company's good manufacturing practices.
  • Action
    No action is required on customers who have purchased the LIFEPAK defibrillators prior to the signing of the commitment agreement by Physio-Control / Medtronic (April 25, 2008). The equipment in use must be used normally by users and spare parts can be ordered from Physio-Control / Medtronic.

Device

EXTERNAL DEFIBRILLATORS: LIFEPAK 12 (Anvisa Reg. 10339190080); LIFEPAK 20 (Anvisa Reg. 1033919017...

Manufacturer

Physio-Control Inc.; Medtronic Comercial Ltda
  • Source
    ANVSANVISA