Events

Alerta De Seguridad para Humidifier

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Fisher & Paykel Healthcare Limited.

¿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
    I1607-298
  • Número del evento
    2014DM-0011418
  • Fecha
    2016-07-26
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=130
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer affirms that it will update the operation instructions of the referenced devices in order to include the verification to verify that the sound of the alarms is audible before use in each patient, ensuring the correct operation of the speaker, leading to prevent them from arising. possible adverse events on patients.

Device

Humidifier
  • Modelo / Serial
    AIRVO 2 and myAIRVO 2, References PT101xx and PT100xx, serial 120521yyyyyyy until 160605yyyyyyy.
  • Descripción del producto
    The MY AIRVO 2 is intended for the treatment of patients who breathe spontaneously and who would benefit from the administration of high-flow heated and humidified respiratory gases. Patients who have undergone surgery to receive a bypass in the upper respiratory tract would also fit within this group. The flow can be between 2 - 60 l / min according to the patient's interface. The MY AIRVO 2 should be used in patients at home or in long-term care centers. The AIR 2 is intended for the treatment of patients who breathe spontaneously and who would benefit from the administration of heated and humidified high-flow respiratory gases. Patients who have undergone surgery to receive a bypass in the upper respiratory tract would also fit within this group. The flow can be between 2 - 60 l / min according to the patient's interface. The AIRVO 2 should be used in hospitalized patients or in long-term care centers.
  • Manufacturer
    Fisher & Paykel Healthcare Limited

Manufacturer

Fisher & Paykel Healthcare Limited