UK MHRA Medicines Brief

Headline

MHRA issues National Patient Safety Alert for 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, covering ResMed Astral 100 and 150 ventilators and associated Printed Circuit Board Assembly spare parts manufactured before October 2024. A confirmed device fault can cause unexpected interruption of ventilation therapy, posing a direct risk of patient harm.

Bottom Line

The MHRA National Patient Safety Alert places a mandatory response obligation on all healthcare organisations in England operating or holding ResMed Astral 100 and 150 ventilators, or stocking associated Printed Circuit Board Assembly spare parts manufactured before October 2024. The confirmed fault creates a direct risk of ventilation therapy interruption in patients who are ventilator-dependent. The alert's mandatory framework requires organisations to complete and document corrective actions within the timeframes specified in the ResMed Field Safety Notice. Biomedical engineering, procurement, and clinical governance functions each carry distinct response obligations under this alert.

Key Regulatory Signals

• Ventilator Fault Confirmed Across Two Device Models: ResMed has confirmed a fault in the Astral 100 and Astral 150 ventilators that can cause unexpected interruption of ventilation therapy. All units and associated Printed Circuit Board Assembly spare parts manufactured before October 2024 fall within scope of the Field Safety Notice.
• Healthcare Providers Must Act on the Field Safety Notice: Hospitals, community care providers, and home ventilation services holding or deploying affected devices are required to review the ResMed Field Safety Notice and take the corrective actions it specifies. Failure to act carries direct patient safety liability under the MHRA's National Patient Safety Alert framework.
• MHRA National Patient Safety Alert Mandates Organisational Response: A National Patient Safety Alert issued by the MHRA requires NHS and independent healthcare organisations to complete defined actions within set timeframes. This is not an advisory communication; it carries a mandatory response obligation for registered healthcare providers in England.
• Spare Parts Supply Chain Is Within Scope: The alert extends beyond deployed devices to Printed Circuit Board Assembly spare parts manufactured before October 2024. Biomedical engineering teams and procurement functions holding these components in inventory must assess whether affected parts remain in stock or have been installed.

Regulatory Delta

- No prior National Patient Safety Alert has been issued against the Astral 100 or 150 product line; this is the first MHRA alert at this tier for these specific devices.

- The scope extension to Printed Circuit Board Assembly spare parts manufactured before October 2024 broadens the affected population beyond deployed devices to inventory and service supply chains.

- The MHRA National Patient Safety Alert framework operates in coordination with NHS England's patient safety infrastructure, requiring organisational-level sign-off on completed actions rather than individual clinical response alone.

Materiality Classification

HIGH — This action carries confirmed regulatory impact beyond its home jurisdiction.

Intelligence Outlook

Monitor the MHRA device alerts register and NHS England patient safety communications for confirmed action deadlines, updated Field Safety Notice guidance from ResMed, and any escalation of this alert's classification.