Events

Alerte De Sécurité sur Defibrillator, Medtronic brand, Lifepak CR Plus model, ANVISA registration no. 10339190167, manufactured between November 2004 and August 2005.

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 Medtronic Physio Control.

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
    830
  • Date
    2006-05-09
  • 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
    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.
  • Cause
    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