Events

Alerta De Seguridad para Intensive Care Respirators

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
    234
  • Fecha
    2000-12-15
  • 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
    Ecri member hospitals have reported that clinicians are not responding quickly to critical alarms that are more musical in the latest intensive care respirator model. they report that the reason for all this is the non-recognition of alarms in more musical tones as alarms of urgency by the clinicians themselves. ecri reports that a delayed response may compromise the patient's condition or result in death.
  • Acción
    ECRI recommends (1) Please advise the staff in charge of this ECRI report and the alarm recognition problem. (2) Establish and initiate a program of awareness and recognition of alarms on respirators. (3) Ensure that all respirator patient care personnel are familiar with the importance and urgency of alarms with a more musical sounding of these respirators. For more information, contact your local representative or directly with ANVISA's Technovigilance at 0xx61-448-1331.

Device

Intensive Care Respirators
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA