UK MHRA Medicines Brief

Headline

MHRA issues National Patient Safety Alert on ResMed Astral 100 and 150 ventilators over unexpected therapy interruption risk

Executive Summary

The MHRA issued National Patient Safety Alert NatPSA/2026/004/MHRA on 17 August 2026, identifying a fault in ResMed Astral 100 and 150 ventilators and associated Printed Circuit Board Assembly spare parts manufactured before October 2024. An internal supercapacitor leaking electrolyte can cause unexpected interruption of ventilation therapy, with potential for serious injury or death.

This alert carries immediate clinical risk implications for affected NHS organisations.

Bottom Line

The MHRA alert covers all Hospital Trusts, Health Boards, and independent healthcare providers delivering NHS, community, home ventilation, and private healthcare services operating ResMed Astral 100 and 150 ventilators and associated PCBA spare parts manufactured before October 2024. The alert sets a master deadline of 17 February 2027 for eight specified actions, with two sub-deadlines requiring completion within one month of the alert date: confirmation of backup ventilation access for all ventilator-dependent patients, and patient-specific clinical risk assessments. Cresthaven reading: the combination of a global PCBA supply constraint, an unrecoverable device fault, and a life-sustaining therapy context makes prompt confirmation of backup ventilation arrangements the central practical priority for affected organizations.

Key Regulatory Signals

• Device Fault Renders Ventilator Inoperable: An internal supercapacitor in affected Astral 100 and 150 ventilators may leak electrolyte, damaging specific circuitry and causing immediate, unrecoverable cessation of ventilation therapy. Once the fault occurs, the ventilator cannot be restarted. ResMed reports an occurrence rate of 0.1% over the device's eight-year service life.
• Life-Sustaining Therapy at Risk Across Hospital, Community, and Home Settings: Astral ventilators provide life-sustaining ventilation for adults and children, including tracheostomy-ventilated, ventilator-dependent, and mouthpiece-ventilated patients. The alert identifies patients requiring ventilation for 14 or more hours per day, those with tracheostomies, and paediatric patients as priority risk groups for clinical assessment.
• Global Supply Constraints Limit Corrective Action Timeline: Replacement PCBAs are subject to global supply constraints, and ResMed states it cannot currently provide a definitive timeline for completing corrective actions across all affected devices. Available replacements are being prioritized for patients according to highest clinical risk. Organizations unable to obtain suitable replacements are directed to escalate through local procurement and the DHSC National Supply Disruption Response service.
• Eight Discrete Actions Required of Healthcare Organizations by 17 February 2027: The alert sets out eight actions for all Hospital Trusts, Health Boards, and independent healthcare providers delivering NHS, community, home ventilation, and private healthcare services. Actions include circulating the Field Safety Notice within two working days, identifying all affected devices including those in community and home settings, confirming backup ventilation access for all ventilator-dependent patients within one month, and completing patient-specific clinical risk assessments within one month. Cresthaven reading: organizations operating affected devices in home and community settings face the same action obligations as acute hospital settings under the alert's scope.
• Executive-Level Coordination Advised for Implementation: The alert states that implementation should be coordinated by an executive leader, or an equivalent role in organizations without executive boards. The alert designates this as a safety-critical and complex National Patient Safety Alert.

Regulatory Delta

No direct MHRA precedent for a National Patient Safety Alert on ResMed Astral ventilators has been identified. This alert follows ResMed's own Field Safety Notice and escalates the matter to NHS-system level, with executive coordination advised.

The alert introduces a supply-constraint dimension absent from standard device safety alerts. ResMed cannot currently provide a definitive timeline for completing corrective actions across all affected devices, and available replacements are being prioritised for patients according to highest clinical risk. The DHSC National Supply Disruption Response service is named as the escalation route for procurement failures, indicating cross-departmental coordination between MHRA and DHSC on this action.

Materiality Classification

MEDIUM — A National Patient Safety Alert at the MHRA's safety-critical tier requiring eight discrete actions from a defined population of healthcare organizations by 17 February 2027, with two one-month sub-deadlines; scope extends beyond a single facility to all providers operating affected devices across hospital, community, home, and private settings.

Time Horizon

implementation — 2027-02-17

Intelligence Outlook

Monitor MHRA and ResMed for updates to the Field Safety Notice, including any revised corrective-action timeline as global PCBA supply constraints evolve, and for any escalation of this alert's classification.