Events

Alerta De Seguridad O Notificaciones De Seguridad para Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Acutronic Medical Systems AG.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Fecha
    2018-12-21
  • Fecha de publicación del evento
    2018-12-21
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/fabian-ncpap-evolution-fabian-therapy-evolution-and-fabian-hfo-risk-of-total-loss-of-patient-ventilation-mda-2018-037
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Manufactured by acutronic medical systems ag – ventilator may switch off without user input, deliver incorrect ventilation or may fail to alarm.
  • Acción
    Identify all affected ventilators – see the Problem section of this alert or the manufacturer’s Field Safety Notices (FSNs) reference FSCA 18-003 and FSCA 18-004. Use an alternative ventilator for treatment if available. If no alternative is available, carry out – and document – a risk assessment based on a clinical risk-benefit analysis before using the ventilator. If you continue to use an affected ventilator, make sure you follow the instructions in the manufacturer’s FSNs and be extra vigilant. Disconnect any ethernet connections from the device. All affected ventilators that have unexpectedly shut down or had power cycling should be removed from service. Complete the End User Response form(s) and return to Kevin.Nash@inspiration-healthcare.com. If you are affected by both FSNs, you must return both forms. Report any incidents or complaints involving this product to info@acutronic-medical.ch

Device

Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO

Manufacturer

Acutronic Medical Systems AG
  • Dirección del fabricante
    Acutronic Tel: +41 44 729 70 80info@acutronic-medical.chUK Distributor contacts Inspiration Healthcare Kevin Nash, Quality and Compliance Engineer Tel: 0127 352 6504 Kevin.Nash@inspiration-healthcare.com
  • Empresa matriz del fabricante (2017)
    Acutronic Medical Produktion Ag
  • Source
    MHRA