This is an equipment safety alert update for those using the Fabian Neonatal Ventilators (Fabian HFO, Fabian HFOi, Fabian+nCPAP) for conventional ventilation in the Volume Guarantee (VG) mode.
The links below relate to the urgent 'Field Safety Notice' issued by the manufacturers and approved by the European competent authority (Swiss Medic). This will now be passed on to MHRA. The notice is essentially asking clinicians not to use the VG function in Fabian ventilators during conventional and HFOV ventilation for patient safety issues as was highlighted on 3 September 2020 in a safety alert.
At the time of the alert investigations were still ongoing, so peer groups were advised to risk assess the continuing use of the VG function on the Fabian ventilators and to consider using different ventilators for this particular mode.
Following completion of the investigation, the manufacturers now recommend not using VG mode on the Fabian ventilators until a software fix is found (the expected time frame is at least 3 months). It is safe to use other modes of ventilation and non-invasive respiratory support on the Fabian ventilators.
We advise that you report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate (links below for England, Scotland, Northern Ireland, Wales). You should also report directly to the manufacturers if your local or national systems do not.
Northern Ireland: https://www.health-ni.gov.uk/articles/reporting-adverse-incident