Events

Alerta De Seguridad para External Automated Defibrillator

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

¿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
    553
  • Fecha
    2002-03-08
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    An ecri member hospital reported that its defibrillators will discharge excessive pediatric patient energy when operated in the automatic mode of the external defibrillator (aed), sometimes referred to as advisory mode. in this mode, the defibrillators selected the first level of shock energy used for adults. depending on the model, this energy level will range from 120 to 200 joule. an injury can occur if the child takes sock with these energies.
  • Acción
    (Note: Refer to the original report quoted below to use logical reasoning following recommendations.) ECRI recommends the following: (1) Alert all users of Automatic External Defibrillator (AED) or manual defibrillators and cardioverters with automatic operation for this report. (2) Determine in your hospital that any existing AEDs are approved for use in pediatrics. Tell the clinical staff that there are no other automatic external defibrillator devices available for use in pediatric patients. (3) Do not store pediatric defibrillation pads along with standard defibrillation devices that are not approved for pediatric use. For manual defibrillators incorporating AED capability, pediatric defibrillation electrodes can be stored together with the unit, but trainings should emphasize that the unit can be used in the external defibrillator mode in AED mode to defibrillate the infant patient. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

External Automated Defibrillator
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA