Field Safety Notice Resmed Astral 100 and Astral 150 Ventilators (ICN 3402)

NHSSC: 35

Alert:

• Resmed has issued a Field Safety Notice affecting a subset of Astral 100 and Astral 150 ventilators.
• An internal electrical component (supercapacitor) may leak electrolyte over time.
• In rare cases, this may damage specific circuitry on the Ventilator’s printed circuit board assembly (“PCBA”), causing the ventilator to inadvertently enter a fail-safe state.
• If the issue occurs while the Ventilator is delivering therapy the therapy will stop.
• If the issue occurs while the Ventilator is in standby and therapy is initiated, therapy will not start.
• In both cases the ventilator is no longer able to deliver therapy and alternative means of ventilation must be provided.
• Patients receiving ventilation support require continuity of care. In the event of a therapy interruption, an alternative means of ventilation should be implemented promptly in accordance with local clinical procedures.

Products Affected:

• Two products are affected.
• The two affected products are available from NHS Supply Chain’s eDirect route:

• Resmed has issued a customer Letter advising these products are unavailable due to sustained manufacturing constraints affecting critical components, and available resources being prioritised to support corrective actions and to ensure continuity of care for patients currently using affected Astral ventilators.
• The supplier is unable to advise when normalised supply with resume.
• The two affected products are now suspended and unavailable to order.
• Potential alternatives are available through our online catalogue.
• Please refer to the attached product listing, Field Safety Notice and customer letter for more information on the affected products.
• Where potential alternatives are identified, customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.
• One of the affected products was previously available from NHS Supply Chain as:

• This product code was replaced by product code FFC85017 and is no longer available to order.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Complete the Customer Acknowledgement Form, page 7 of the Field Safety Notice by emailing: astralresponse@resmed.com
• Avoid removing affected ventilators from use unless an appropriate alternative means of ventilation is immediately available.
• Customers are strongly encouraged to undertake local clinical risk assessments of all affected patients as a priority in line with the Field Safety Notice.
• Attention should be given to patients with a higher dependency on ventilatory support, including those who are ventilator-dependent, require invasive ventilation, or have limited ability to maintain spontaneous ventilation.
• These patients should be prioritised for review and appropriate risk mitigation actions in line with local clinical judgement and the Resmed patient prioritisation framework.
• For clinical, technical and device-specific queries relating to affected Astral ventilators, please contact Resmed directly through their established support channels.
• We will update this ICN with more information regarding product availability once known.
• If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.