Dive Brief:
- Resmed has contacted customers about a ventilator issue linked to five serious injuries, the Food and Drug Administration said Wednesday.
- A subset of Astral 100 and Astral 150 ventilators can inadvertently enter a fail-safe state and stop delivering therapy, creating a risk of serious injury or death.
- Resmed 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 last week.
Dive Insight:
The notices relate to Astral 100 and 150 ventilators with supercapacitors that may leak over time. If the component leaks, it can damage circuitry on the printed circuit board assembly and cause the device to enter a fail-safe state. Devices that enter that state while in use stop delivering therapy. If the device is on standby when it enters the state, it will not 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 said.
As of June 23, Resmed had reported five serious injuries and no deaths associated with the issue, the FDA said. Resmed’s letter to customers noted five reports of adverse events, one of which was serious. All patients recovered after intervention, Resmed said. The company’s analysis of global post-market and service data found that about 0.1% of devices suffer leaks that cause them to enter a fail-safe state.
To prevent further incidents, Resmed 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 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.
The company expects the supply constraints to affect the availability of new Astral ventilators. Because access to new devices may be limited, Resmed has recommended that healthcare providers prioritize alternative ventilator options for new patients. The company also advised providers with devices that are beyond the expected eight-year service life to consider moving patients to alternative ventilators.
