Devices

Early Alert on Drager Anesthesia Workstations

FDA has issued an early alert warning healthcare providers about a potentially high-risk problem involving certain anesthesia workstations manufactured by Drager that could cause mechanical ventilation failure during use. The alert affects the company’s Atlan A350 and Atlan A350 XL anesthesia workstations, which are used during surgical and diagnostic procedures to provide inhaled anesthesia and ventilatory support for adults, children and newborns.

According to FDA, the issue stems from a manufacturing defect involving the ventilator motor assembly that could prevent mechanical ventilation from starting or cause ventilation to fail during a procedure.

If the malfunction occurs while the device is in use, the workstation displays a “Ventilator error!!!” message, FDA said. Although manual ventilation and spontaneous breathing modes remain available, clinicians may need to manually ventilate patients to prevent serious injury.

The agency warned that ventilation failure could lead to severe complications including hypoxia, bradycardia, cardiac arrest and death.

FDA said Dräger is expanding a correction initially issued 10/2024 to include additional affected devices.

On May 7, the company sent customers a notice advising facilities to continue using the workstations only under close and constant supervision until the ventilator motor assembly can be replaced by company service representatives who will contact customers to schedule repairs.

As of 5/6, FDA said it had received no reports of injuries or deaths linked to the issue.

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