UPDATED: FDA issues early alert of potential issue with Resmed Astral

WASHINGTON - The U.S. Food and Drug Administration (FDA) on July 15 issued an early alert to notify the public of a potentially high-risk device issue with certain Resmed Astral 100 and Astral 150 ventilators.

The FDA said it is aware that Resmed has issued a voluntary Global Medicare Device Correction / Field Safety Notice for its Astral 100 and Astral 150 ventilators built prior to October 2024 due to the potential of a component called a supercapacitor leaking over time. The leakage may damage internal parts and result in the vents incorrectly entering a protective safety state.

Resmed advises patients to continue using their ventilator as directed by their health care providers and to follow instructions provided in the Field Safety Notice and Astral User Guide.

“Patient safety is Resmed’s top priority and is rooted in our longstanding commitment to quality, integrity and patient care,” the company said in a statement to HME News. “Resmed continuously evaluates the safety and performance of its products through ongoing monitoring, post-market assessments and quality reviews to uphold the highest standards of quality, regulatory compliance and patient care.”

What's the role of health care providers and distributors

The FDA advises health care providers and distributors to:

• 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 health care 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 judgment.
• 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 two-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.

What’s the issue

If the issue occurs while the vent is delivering therapy:

• Therapy stops
• A high-priority audible alarm (maximum volume alarm) activates.
• The ventilator screen may display Therapy alarms and a Safety System Fault red screen.
• When the “Vent Stop” button is pressed, the ventilator screen displays System Fault 140.

If it occurs while the vent is on standby:

• A high-priority audible alarm (maximum volume alarm) activates. The ventilator screen may not display a message.
• If therapy is started, therapy will not start.

In both cases, the vent will no longer be able to deliver therapy and alternative ventilation support must be started immediately.

What’s the immediate action

Resmed reinforces the importance of following instructions in the Astral User Guide, particularly:

• 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.

What Resmed is doing

Resmed says it is taking a phased approach to address the issue, due to the limited availability of replacement parts. It says patients who may be at the highest risk if ventilation stops unexpectedly will be the first priority.

“Resmed is continuing to increase the availability of replacement parts and evaluate additional correction options for affected ventilators,” the company stated in a June 25 letter to patients and caregivers.