FDA issues early alert on Resmed Astral ventilators due to electrical component failure risk
The FDA’s Center for Devices and Radiological Health has released an early alert warning about a possible high-risk problem with certain Resmed Astral ventilators.
A defective electrical component in the main board could stop or interrupt breathing support, which may lead to serious injury or death.
Resmed has advised customers to replace the affected boards with new parts as soon as they become available, and patients should keep using the device unless directed otherwise by a clinician.
The notice applies to Astral 100 and Astral 150 units manufactured before October 2024, identified by specific serial numbers and unique device identifiers.
Owners are urged to verify the board installed in their machines and follow the replacement instructions promptly.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Early Alert: Ventilator Issue from Resmed”
read at fda medwatch ↗
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