Alerta De Seguridad para Fan Model DX-3012. Series under risk: 140 units, disclosed by the company its risk statement (see annex). Anvisa Registry n ° 10293490037.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Dixtal Biomédica Indústria e Comércio 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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    During normal operation, the ventilator may suspend ventilation without any interaction or during the calibration process of the equipment. This process takes an average of 8 seconds, during which time there will be no ventilation for the patient. After the fault occurs, an emergency mode with high priority alarm is activated. Emergency ventilation uses a PCV mode with parameters set to be supported by different operating categories. To date, there are no reports of adverse events related to this problem according to Dixtal. The period of discontinuation of ventilation can cause serious consequences depending on the patient's clinical condition until emergency ventilation with a high priority alarm is activated. The repercussions vary from only a small respiratory discomfort almost imperceptible to the patient, to severe hemodynamic repercussions requiring medical intervention. Emergency ventilation is activated in PCV mode, which is safe, including the neonatal population, but may not be ideal for the patient at that time and therefore requires some adjustments by the medical staff.
  • Causa
    Model dx-3012 fans may present technical failure, causing patient ventilation to be suspended for 8 seconds or during calibration of the equipment.
  • Acción
    Field correction. Check that the serial number of the appliance, marked on the label on the rear of the product, is one of those quoted in this document. Immediately contact the authorized Philips Dixtal network for corrective maintenance.


  • Empresa matriz del fabricante (2017)
  • Source