Events

Safety Alert for Defibrillator, Medtronic brand, Lifepak CR Plus model, ANVISA registration no. 10339190167, manufactured between November 2004 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
    830
  • Date
    2006-05-09
  • 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
    Medtronic Comercial Ltda announces that the substitutions will be carried out until September of 2009, and will be carried out by Medtronic Comercial Ltda. 2006. **** Update (11/05/07): Medtronic Comercial Ltda informs that it has already closed the exchange of the affected equipment and that it only awaits the consolidation of loads and the return of some units to finish the destruction of the equipment collected.
  • Reason
    Medtronic has identified that one of the printed circuit boards (pcbas) may be contaminated with solder flux and may cause a short circuit causing equipment failure during use. two factors caused this problem: 1. the solder flux was applied incorrectly and; 2. the cleaning process used to remove the solder flux has not been done correctly. information on the action as well as the list of affected series numbers can be found at http://www.Medtronic-ers.Com/notices/cr.
  • Action
    The manufacturer is sending a communication of this event to each Institution where they were marketed and distributed for scheduling the equipment exchange. The manufacturer is also implementing a more rigorous control process to prevent contamination in the welding flow occurring again.

Device

Defibrillator, Medtronic brand, Lifepak CR Plus model, ANVISA registration no. 10339190167, manuf...

Manufacturer

Medtronic Physio Control
  • Source
    ANVSANVISA