Early Alert: Ventilator Issue from Resmed

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

Figure 1. Astral 150.

The FDA is aware that Resmed has issued a letter to affected customers recommending that certain Astral 100 and Astral 150 ventilators be corrected as soon as replacement parts become available. Patients should NOT stop using the ventilator unless they are instructed by their clinician.

Affected Devices:

Astral 100 ventilators built prior to October 2024
- Serial Number: less than 22241890149
- Unique Device Identifier (UDI): 00619498003259, 00619498270019
Astral 150 ventilators built prior to October 2024
- Serial Number: less than 22241890149
- Unique Device Identifier (UDI): 00619498270033
Astral 100 PCBA spare parts built prior to October 2024
- Characters 2–8 on the PCBA or ventilator user interface are less than 2707658
- Unique Device Identifier (UDI): 00619498290512
Astral 150 PCBA spare parts built prior to October 2024
- Box Serial Number: less than 22241978070
- Unique Device Identifier (UDI): 00619498290529

What to Do

These devices are used to provide continuous or intermittent ventilatory support to patients at home, in the hospital, and portable situations, and interrupted or failed therapy may result in serious injury or death. DO NOT stop using these ventilators. Immediately determine whether the main board currently installed in the ventilator is affected by this issue. Ventilators fitted with a main board that is not affected by this issue are not impacted. Ensure all affected users have backup ventilation equipment available and ready for immediate use while awaiting the correction from Resmed.

On June 25, Resmed sent all affected customers a letter recommending the following actions:

Patients:

Do not stop using your ventilator unless advised by your clinician.
Your healthcare provider or service provider will contact you if your ventilator requires inspection, servicing, or corrective action.
All caregivers should be appropriately trained, have up-to-date training, and feel confident in responding to alarms and emergency situations. If you are unsure how to respond to an alarm, contact your healthcare provider or clinician for guidance.
Ensure that backup ventilation equipment (such as a backup ventilator or manual resuscitator) is available, regularly checked, and ready for immediate use if needed.
For ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device. Failure to do so may result in patient injury or death.
Ventilator-dependent patients should be continuously monitored by qualified personnel or adequately trained carers. These personnel and carers must be capable of taking the necessary corrective action in the event of a ventilator alarm or malfunction.

Health Care Providers and Distributors:

Check all ventilators to determine whether the main board currently installed is affected by this issue. If a ventilator has previously had its PCBA replaced, the replacement PCBA should be verified. Ventilators fitted with a main board that is not affected by this issue are not impacted.
Immediately provide a copy of this notice, together with the physician letter and patient/carer communication, to all relevant healthcare professionals, patients, and carers.
Reinforce adherence to the Astral User Guide and Clinical Guide instructions, including ensuring that ventilator-dependent patients are appropriately monitored, that care providers are trained and confident in responding to ventilator alarms and emergency situations, and that appropriate alternative ventilation equipment is functional, regularly checked, and immediately available where required.
Do not remove an affected ventilator from use unless an appropriate alternative means of ventilation is immediately available. If an affected ventilator becomes inoperable, it should be removed from use and replaced with an appropriate alternative means of ventilation. Patients should continue therapy unless otherwise directed by their treating clinician.
Review and assess the affected patients’ clinical needs and their clinical risk category (Tier 1, Tier 2 or Tier 3) using Appendix A (provided in Resmed’s health care provider letter) and clinical judgement.
Arrange inspection of affected ventilators in accordance with the Phase 1 Inspection and Correction Strategy in Appendix A. Return ventilators to an authorized service center when required.
Continue to follow Resmed service and maintenance processes, including the 2-year preventative maintenance schedules and current Technical Service instructions (including Tech Note 1063720 and subsequent updates).
Identify affected ventilators within your control and review the serial number list provided by Resmed.
Monitor communications from Resmed regarding this issue. Resmed will provide further updates and instructions directly to affected customers via email or other appropriate communication channels as additional information becomes available.
For new patients, prioritize alternative ventilator options due to the significantly constrained availability of Astral ventilators.

Service Centers:

Identify any PCBA spares in your possession with a serial number below 22241978070, remove them from available service inventory to prevent further use, and contact
Resmed for further instructions.
Perform servicing, corrective actions and data collection in accordance with the latest Technical Service instructions, including Tech Note 1063720. As Technical Service instructions are updated, progressively expand replacement activities in line with updated guidance.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

Resmed stated that in a subset of Astral 100 and Astral 150 ventilators, they have identified that a component, called a supercapacitor, may leak over time. The leakage may damage specific circuitry on the printed circuit board assembly (PCBA). This can result in the ventilator inadvertently entering a fail-safe state.

If the issue occurs while the ventilator is delivering therapy:

Therapy stops.
A high-priority audible alarm (maximum volume alarm) activates.
The user interface may display therapy alarms and a Safety System Fault red screen.
When the “Vent Stop” button is pushed, the user interface displays System Fault 140.
If the issue occurs while the ventilator is in standby:

A maximum volume alarm activates. A user interface message may not be displayed.
If therapy is initiated, therapy will not start.

In both cases the ventilator is no longer able to deliver therapy. Alternative means of ventilation must be provided.

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.

At this time, the availability of PCBAs is significantly constrained, and it is not possible to immediately correct all affected ventilators. As a result, Resmed is implementing a prioritized and phased approach initially focused on inspection and risk mitigation activities during routine service interactions for patients at highest clinical risk.

Resmed is continuing to evaluate potential additional corrective action pathways for the affected population. Further communication and updated instructions regarding any additional actions that may be required will be provided as they become available.

These supply constraints are also expected to affect the availability of new Astral ventilators. Accordingly, alternative ventilator options should be prioritised for new patients, noting that availability may vary by product and country.

As of June 23, Resmed has reported five serious injuries and no deaths associated with this issue.

Device Use

The Astral 100 and Astral 150 ventilators provide continuous or intermittent ventilatory support for patients weighing more than 5 kg who require mechanical ventilation. The ventilators are intended for use in home, institutional/hospital, and portable settings for both invasive and non-invasive ventilation.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact their local Resmed representative via www.resmed.com/contact.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.