Events

Alerte De Sécurité sur LIFEPAK DEFIBRILLATOR 20. Anvisa Record: 10339190171.

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 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
    1023
  • Date
    2010-06-14
  • 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 company received reports of problems associated with the two power supplies of the Lifepak 20 equipment (AC and DC power). AC power failures have been related to specific equipment failures due to network overload, preventing operation with AC power and battery charging. DC power failures have been attributed to waste from the solder flux underneath the component, which causes loss of current in the equipment. For further details, refer to the Field Safety Notice at http://portal.anvisa.gov.br/wps/wcm/connect/3913658042d9e5edba3bbb4817069f5c/Carta+ao+Cliente.pdf?MOD=AJPERES.#### Update ( 24/09/2012): The company informed that it is changing the scope of the field action (reduction of the number of units to be repaired) and that it intends to finalize the field action in Brazil within 6 to 9 months.
  • Cause
    Possibility of failure of the power supply of the equipment.
  • Action
    The following actions are recommended to users of the product: (1) Verify that you have the Lifepak 20 equipment in your inventory; (2) Keep Lifepak 20 defibrillators / monitors operating normally, connected to AC power and keep DC power (continuous current - battery) in continuous charging whenever possible; (3) Follow the recommended daily steps in the Operator's Roadmap (Section 7, Appendix D) to check for possible AC or DC power failures before use; (4) If you identify power failures on some equipment, identify it and segregate it (substitute for another if possible) and contact the product registration holder in Brazil (Medtronic Comercial Ltda.) Or your representatives (Pro Life Medical Equipment and DMAV Medical Support).

Device

LIFEPAK DEFIBRILLATOR 20. Anvisa Record: 10339190171.

Manufacturer

Medtronic Comercial Ltda
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA