Events

Safety Alert Or Field Safety Notices for Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Acutronic Medical Systems AG.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2018-12-21
  • Event Date Posted
    2018-12-21
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    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 / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Manufacturer Address
    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
  • Manufacturer Parent Company (2017)
    Acutronic Medical Produktion Ag
  • Source
    MHRA