Events

Alerte Ou Avis De Sécurité sur Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Acutronic Medical Systems AG.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Date
    2018-12-21
  • Date de publication de l'événement
    2018-12-21
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    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
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Manufactured by acutronic medical systems ag – ventilator may switch off without user input, deliver incorrect ventilation or may fail to alarm.
  • Action
    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
  • Adresse du fabricant
    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
  • Société-mère du fabricant (2017)
    Acutronic Medical Produktion Ag
  • Source
    MHRA