Events

Alerta De Seguridad para LIFEPAK DEFIBRILLATOR 20. Anvisa Record: 10339190171.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Medtronic Comercial Ltda.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1023
  • Fecha
    2010-06-14
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    Possibility of failure of the power supply of the equipment.
  • Acción
    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
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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