Alerta De Seguridad para Neonatal / Pediatric Ventilator

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 F. Stephan Gmbh Medizintechnik.

¿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
    I1603-118
  • Número del evento
    2009EBC-0004429
  • Fecha
    2016-03-22
  • País del evento
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
  • 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 reports that the mechanical ventilation was interrupted, due to an incorrect length of the patient circuit made in an artisanal way, situation that caused the system to erroneously calculate the pressure of the circuit, interpreting its increase as an obstruction of the endotracheal lane causing the opening of the safety valve and the alarm related, which could lead to potential adverse events on the patients.

Device

  • Modelo / Serial
    HFO (High Frequency)
  • Descripción del producto
    Mechanical ventilation of premature babies, babies and small children under 20kg. In particular, they are used in the case of respiratory failure caused by ladifusion or respiratory mechanical disorder.
  • Manufacturer

Manufacturer