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Early Alert: Ventilator Issue from Resmed
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. In a subset of Astral 100 and Astral 150 ventilators, Resmed has identified that a component (called a “supercapacitor”) may leak over time. The leakage may damage specific circuitry on the printed circuit board assembly. This can result in the ventilator inadvertently entering a fail-safe state and being unable to deliver therapy. 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.
As of June 23, Resmed has reported five serious injuries and no deaths associated with this issue.
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.
Questions?
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.
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