FDA Flags Possible Circuit Issue in Some Resmed Astral Ventilators

The U.S. Food and Drug Administration has issued an early alert warning customers about possible issues with some of Resmed’s Astral ventilators.

The FDA said that Resmed discovered the supercapacitor in a subset of Astal 100 and 150 ventilators built before October 2024 (serial number below 22241978070) may leak over time. The leakage can damage circuitry on the printed circuit board assembly (PCBA), causing the ventilator to enter a fail-safe mode.

If this happens when the device is providing therapy, the therapy stops and a maximum volume alarm sounds. The user interface might show therapy alarms with a “Safety System Fault” red screen, and pushing the “vent stop” button changes the display to “System Fault 140.”

As of June 30, the company reported five serious injuries and no deaths related to the issue.

If the ventilator’s in standby mode, Resmed said the alarm will sound but the user interface message might not show. The company also cautioned that therapy won’t start if it’s initiated.

Because the devices provide continuous or intermittent ventilatory support, the company advised on June 25 not to stop using the ventilators due to the risk of serious injury or death. Resmed said to determine if the main board installed in the ventilator is affected and have backup devices available while awaiting correction.

The company also noted that PCBA supply is currently constrained and it can’t immediately correct all of the impacted ventilators. It said it will begin a prioritized, phased approach that targets inspection and risk mitigation during routine service interactions for the highest-risk patients.