The FDA has issued an early alert for certain Draeger anesthesia workstations tied to a manufacturing issue that could cause mechanical ventilation to fail before or during use.
Affected devices include the Atlan A350 and Atlan A350 XL anesthesia workstations, according to a May 19 FDA notice. The issue stems from a manufacturing error involving the ventilator motor assembly. If the failure occurs before use, mechanical ventilation cannot begin. If it occurs during a procedure, the workstation displays a “ventilator error” message and mechanical ventilation may stop, though manual ventilation and spontaneous breathing functions may persist.
The FDA said use of the affected devices could lead to serious adverse events, including hypoxia, bradycardia, cardiac arrest and death. As of May 6, the agency had received no reports of injuries or deaths linked to the issue.
Draeger advised customers to continue using the devices only under permanent supervision until the ventilator motor assembly can be replaced. The company said local service representatives will contact customers to schedule repairs.
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