Events

Alerta De Seguridad para HIGH FLOW INSULATOR AND PNEUMOSURE ACCESSORIES. Registration ANVISA: 80005430157. Models: 620-040-600 and 620-040-610. Serial No. of Products Affected: 0804CE394 through 0810CE295.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Stryker do Brasil 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
    960
  • Fecha
    2009-03-17
  • 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 potential effects of the problem are as follows: (a) Delay in surgery caused by the need to restart the insufflator; (b) Delay in surgery caused by need of replacement of the insufflator; (c) If the shut-down occurs and there is no alternative equipment available, there is a risk that the surgery will need to be converted into open surgery; and (d) if the device shuts off during surgery, there is a risk of accidental cutting of the patient's internal organs. Stryker do Brasil Ltda informed that, between January 13 and 16, 2009, the PneumoSure software was updated on all customers affected by the problem. For more information, access the Letter to Product Users (available at www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/960_carta.pdf). UTVIG / ANVISA is following up on this case.
  • Causa
    Sudden equipment shutdown may occur. the equipment can be reconnected, but with the risk of recurrence of the fault at any time.
  • Acción
    The recommended actions for product users are as follows: (1) Check if there is any equipment in your inventory that is affected by this alert; (2) If you locate any affected equipment, check if it has already been corrected in relation to the problem mentioned (check the maintenance records - if you have any questions, contact the registry owner); (3) If the affected equipment has not yet been corrected, segregate it immediately, identifying it properly (with a poster, for example) to prevent inadvertent use of the equipment until the problem is corrected; (4) Contact the record holder (see address in the Manufacturer's description field) and report the existence of equipment at risk.

Device

HIGH FLOW INSULATOR AND PNEUMOSURE ACCESSORIES. Registration ANVISA: 80005430157. Models: 620-040...

Manufacturer

Stryker do Brasil Ltda.
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    ANVSANVISA