MHRA Issues National Patient Safety Alert for ResMed Astral 100 and 150 Ventilators

• ResMed's Astral 100 and 150 ventilators may experience unexpected interruption of ventilation therapy due to a faulty internal supercapacitor.
• The issue can cause serious injury or death if an alternative means of ventilation is not immediately available.
• Healthcare providers must verify that affected patients have access to a functioning backup ventilator or emergency ventilation contingency arrangements.
• Staff should be trained to recognise ventilator alarms and implement emergency procedures.

The interruption of ventilation therapy can have serious consequences, including injury or death if an alternative means of ventilation is not immediately available.

A critical safety issue has been identified in ResMed's Astral 100 and 150 ventilators, which can cause unexpected interruption of ventilation therapy due to a faulty internal supercapacitor. This component may leak electrolyte, damaging the device's circuitry and triggering an alarm that stops ventilation immediately. If this occurs while the ventilator is delivering therapy, it will stop working altogether, requiring alternative ventilation arrangements. In some cases, the user interface may display error messages or a red screen, but in others, the issue may not be immediately apparent. The problem can occur even when the device is in standby mode, where only a high-priority alarm will sound.

The MHRA has issued a National Patient Safety Alert regarding this issue, which affects all hospital trusts, health boards, and independent healthcare providers delivering NHS, community, home ventilation, and private healthcare services. The alert is classified as safety-critical and complex, requiring coordination from an executive leader or equivalent role in organisations without executive boards. ResMed has issued a Field Safety Notice (FSN) to address the problem, which includes affected serial numbers for reference. Replacement parts are currently subject to global supply constraints, with ResMed unable to provide a definitive timeline for completion of corrective actions.

The interruption of ventilation therapy can have serious consequences, including injury or death if an alternative means of ventilation is not immediately available. Although the reported occurrence rate is low at 0.1% over the device's service life of 8 years, healthcare providers must take immediate action to ensure affected patients have access to a functioning backup ventilator or emergency ventilation contingency arrangements. This includes verifying that carers and relevant staff are trained and competent to recognise ventilator alarms, implement emergency procedures, and access urgent clinical support. Healthcare organisations experiencing difficulty obtaining suitable replacement or alternative ventilators should escalate through local procurement arrangements and the DHSC National Supply Disruption Response (NSDR) service.

Healthcare providers must immediately verify that affected patients have access to a functioning backup ventilator or emergency ventilation contingency arrangements, and ensure staff are trained to recognise ventilator alarms and implement emergency procedures.

Source: Original reporting via MHRA National Patient Safety Alert