Events

Safety Alert for External Defibrillator, Brand Medtronic, Model Lifepak 500, ANVISA register 10339190062 manufactured between February 2005 and August 2005.

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

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
    828
  • Date
    2006-04-25
  • 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 Technovigilance Unit - NUVIG / ANVISA is following the actions of the company according to voluntary notification of Medtronic Comercial Ltda. Update (05/15/2006): Medtronic Comercial Ltda informs that the replacements of the equipment will be given until 01/07/2006. ************* Update: 07/20/2006 Medtronic informs that it has begun the recall of the affected products with an expiry date until 08/15/2006. ************* Update 28/08/2006 Medtronic informs the termination of the recall by replacing all notified equipment. Inquiries or clarifications contact the Representative in Brazil, Medtronic Comercial Ltda, (11) 3707-3759, Department of Regulatory Affairs or the Technovigilance Unit / ANVISA.
  • Reason
    The manufacturer has identified that an electrode component may generate an intermittent connection on the printed circuit board (pcba) blades. this component controls a number of functions which may render the device inoperative and therefore unprepared for use in an emergency. at http://www.Medtronic-ers.Com/notices/500 there is a lind for this action, as well as the list of affected series numbers.
  • Action
    Medtronic Comercial Ltda informs that it is contacting each place where the products were distributed and a schedule will be made to exchange the device.

Device

External Defibrillator, Brand Medtronic, Model Lifepak 500, ANVISA register 10339190062 manufactu...

Manufacturer

Medtronic Physio Control
  • Source
    ANVSANVISA