Resmed issues correction for certain Astral vents

SAN DIEGO – 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. At issue: The vents may stop delivering therapy due to an internal component issue.

The company says that in a subset of Astral 100 and Astral 150 vents a component called a supercapacitor may leak over time, potentially causing damage to internal parts and resulting 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 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.