ResMed Astral 100/150 Ventilators Linked to Serious Injuries from Unexpected Therapy Interruption
核心洞察
ResMed (搜索)'s Astral 100 (搜索) and 150 ventilators can enter a fail-safe state due to leaking supercapacitors, causing unexpected interruption of ventilation therapy.
The FDA reported five serious injuries and no deaths as of June 23, while ResMed (搜索)'s analysis found about 0.1% of devices suffer leaks over their 8-year service life.
Replacement circuit boards face significant global supply constraints, prompting a prioritized, phased correction approach focused on patients at highest clinical risk.
ResMed (搜索) has alerted customers to a safety issue affecting a subset of its Astral 100 (搜索) and Astral 150 (搜索) ventilators, which can inadvertently enter a fail-safe state and stop delivering therapy, creating a risk of serious injury or death. The Food and Drug Administration (搜索) (FDA) disclosed the issue on Wednesday, noting that ResMed had reported five serious injuries and no deaths associated with the problem as of June 23.
The issue stems from supercapacitors within the devices that may leak electrolyte over time. If the component leaks, it can damage circuitry on the printed circuit board assembly (PCBA) and cause the ventilator to enter a fail-safe state. Devices that enter this state while in use stop delivering therapy immediately, while devices on standby will fail to deliver therapy the next time the user initiates treatment.
"Patients who are unable to maintain spontaneous ventilation, or who do not have access to adequate monitoring or alternative ventilation, may be at risk of serious injury or death if the fail-safe state is entered and therapy is not restored," the FDA stated.
ResMed (搜索) informed customers of the issue on June 25, asking them to continue using the devices with precautions. The FDA shared the message in an early alert notification. ResMed's letter to customers noted five reports of adverse events, one of which was serious, and stated that all patients recovered after intervention. The company's analysis of global post-market and service data found that approximately 0.1% of devices suffer leaks that cause them to enter a fail-safe state.
Clinical Impact and Affected Population
Astral ventilators are used in hospital, community, and home settings to provide life-sustaining ventilation for adults and children, including tracheostomy-ventilated, ventilator-dependent, and mouthpiece-ventilated patients. Although the reported occurrence rate is low at 0.1% over the device service life of eight years, interruption of ventilation may result in serious injury or death if an alternative means of ventilation is not immediately available.
When the fault occurs during active therapy, a high-priority audible alarm activates, and the user interface may display therapy alarms and a Safety System Fault red screen. If the issue occurs while the device is in standby, a maximum volume alarm activates, and the user interface message may not be displayed. Once the fault occurs, the ventilator becomes inoperable and cannot be restarted, requiring immediate alternative ventilation.
Corrective Action and Supply Constraints
To prevent further incidents, ResMed (搜索) is working to correct all affected ventilators. However, the supply of the circuit boards needed to fix the devices is significantly constrained, preventing the company from immediately correcting all affected ventilators. ResMed cannot currently provide a definitive timeline for completion of corrective actions across all affected devices.
ResMed (搜索) is implementing "a prioritized and phased approach" to corrections, according to the early alert. The company will focus initially on inspection and risk mitigation activities for patients at the highest clinical risk. Available replacement PCBAs are being prioritized for patients according to highest clinical risk.
Regulatory Response and Required Actions
The UK's Medicines and Healthcare products Regulatory Agency (搜索) (MHRA) issued a National Patient Safety Alert (NatPSA/2026/004/MHRA) on 17 August 2026, covering Astral 100 (搜索) and 150 ventilators and associated PCBA spare parts manufactured prior to October 2024. The alert directs all Hospital Trusts, Health Boards, and independent healthcare providers delivering NHS, community, home ventilation, and private healthcare services to complete actions by 17 February 2027.
Required actions include circulating the Field Safety Notice within two working days, identifying all affected devices, and confirming within one month that all affected ventilator-dependent patients have immediate access to a functioning backup ventilator or other emergency ventilation contingency arrangements. Clinicians must implement and document patient-specific clinical risk assessments within one month, prioritizing patients who require ventilation for 14 or more hours per day, have a tracheostomy, are fully dependent on ventilation, are paediatric or otherwise clinically vulnerable, use devices approaching or beyond their expected service life, or live in locations where emergency response may be delayed.
The alert also directs providers not to initiate new patients on Astral devices where suitable alternatives are available, and to consider transitioning patients at highest clinical risk to alternative ventilators where clinically appropriate. Patients should not stop using their ventilator unless advised to do so by their clinical team and an alternative means of ventilation is available.
The most important risk mitigation measure identified is immediate access to backup ventilation where available. Carers should be trained to recognize and respond appropriately to ventilator alarms and emergency procedures, and should be present at all times for patients who are fully ventilator-dependent or unable to independently respond to ventilator failure.