Events

Safety Alert for 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).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Physio-Control Inc.; Medtronic Comercial Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    930
  • Date
    2008-06-30
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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