MHRA: ResMed Astral Ventilator FSN MHRA August 2026 Safety Alert

• The MHRA's August 2026 safety roundup highlights a Field Safety Notice for ResMed Astral 100 and 150 ventilators manufactured before October 2024.
• A leaking internal supercapacitor can damage the Printed Circuit Board Assembly, causing an unexpected and immediate stop of ventilation therapy.
• Though the occurrence rate is low at 0.1%, this issue necessitates immediate alternative ventilation to prevent serious injury or death.
• Global supply constraints are impacting the replacement of affected PCBAs, with prioritization given to patients at the highest clinical risk.
• The MHRA also provided updates on safety notices for Dräger Atlan Anaesthesia workstations and Belzer solutions, reflecting broader regulatory vigilance.

Interruption of ventilation therapy, even for a brief period, carries a significant risk of serious injury or death if an immediate alternative is not available.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a significant safety alert in its August 2026 roundup, focusing on ResMed Astral 100 and 150 ventilators. This Field Safety Notice (FSN) addresses a critical defect concerning Printed Circuit Board Assembly (PCBA) spare parts manufactured before October 2024. The core issue stems from an internal supercapacitor that may leak electrolyte, subsequently damaging specific circuitry within the PCBA and leading to an unexpected interruption of vital ventilation therapy.

Should this fault manifest while the ResMed Astral ventilator is actively delivering therapy, the device will immediately cease operation. Users are alerted by a high-priority audible alarm, and the user interface may display specific therapy alarms alongside a prominent Safety System Fault red screen. If the issue occurs when the device is in standby mode, a maximum volume alarm will activate, though the user interface message might not be displayed. In either scenario, once the fault occurs, the ventilator becomes inoperable and cannot be restarted, necessitating immediate access to alternative ventilation.

ResMed Astral ventilators are indispensable medical devices, providing life-sustaining ventilation across diverse settings including hospitals, community environments, and private homes. They serve a wide patient population, encompassing adults and children, including those who are tracheostomy-ventilated, ventilator-dependent, or utilize mouthpiece ventilation. The reported occurrence rate for this specific defect is low, standing at 0.1% over the device's eight-year service life.

Despite the low incidence, the potential consequences are severe. Interruption of ventilation therapy, even for a brief period, carries a significant risk of serious injury or death if an immediate alternative is not available. Given this critical risk, patients are strongly advised not to discontinue using their ventilator unless explicitly instructed by their clinical team and only when an alternative means of ventilation has been secured.

Addressing the identified defect presents a complex challenge due to global supply constraints affecting replacement PCBAs. ResMed has indicated that it cannot currently provide a definitive timeline for the completion of corrective actions across all affected devices. This situation necessitates a strategic approach to device replacement.

Consequently, available replacement PCBAs are being prioritized for patients based on their highest clinical risk. Organizations encountering difficulties in obtaining suitable replacement or alternative ventilators are encouraged to escalate their needs through established local procurement arrangements. Additionally, the DHSC National Supply Disruption Response (NSDR) service, accessible via nsdr@dhsc.gov.uk, serves as an appropriate channel for further escalation and support.

The MHRA's August 2026 safety roundup also includes updates on other critical medical device issues, underscoring the agency's ongoing commitment to patient safety. In April 2026, Dräger issued a follow-up Field Safety Notice, expanding the number of Atlan Anaesthesia workstation devices affected by a manufacturing defect. This defect, which was the subject of an earlier FSN in October 2024, may lead to piston ventilator failure either before or during use, potentially interrupting ventilation delivery and requiring an immediate transition to manual or spontaneous ventilation. Dräger is actively correcting the affected devices and has issued warnings to users regarding risks and mitigation strategies while these corrective actions are underway. As of July 29, 2026, the manufacturer has reported no confirmed patient injuries or deaths linked to this specific issue.

Furthermore, the MHRA has provided an update regarding previously identified defects with Belzer solutions. These defects included leakage and discolouration, which could result in potentially contaminated fluid and posed a risk of significant patient harm. Corrective action has since been taken by Carnamedica and Bridge to Life, and this new Device Safety Information replaces the advice previously issued in DSI/2023/005, which should no longer be followed.

Source: Original reporting via GOV.UK