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Early Alert: Anesthesia Machine Issue from Draeger, Inc.

The FDA is aware that Draeger, Inc. has issued a letter to affected customers recommending certain anesthesia Machine be corrected prior to continued use. Affected devices:

• Product Names: Atlan A350 and Atlan 350XL anesthesia workstations
• Unique Device Identifier (UDI)/Model:
  • Atlan A350: 04048675556176/8621500
  • Atlan A350 XL: 04048675556183/8621600

Draeger, Inc., is expanding their October 2024 correction to include additional Atlan A350 and A350 XL anesthesia workstations. This correction is due to a manufacturing error that may cause the piston ventilator to fail before use or mechanical ventilation to fail during use.

If the error occurs before use, such as in standby or system test mode, mechanical ventilation cannot be started. If the error occurs during a procedure, the mechanical ventilation may fail, and the device alerts the user by displaying the "Ventilator error!!!" message. Manual ventilation or spontaneous breathing remains possible in both cases. It may be necessary to manually ventilate the patient to prevent injury.

The use of affected product may cause serious adverse health consequences, including lack of oxygen (hypoxia), loss of the ability to expand the lungs (lung recruitment), slow heart rate (bradycardia), sudden heart stop (cardiac arrest), and death.

Questions?

Customers in the U.S. with questions about this recall should contact Draeger Service Technical Support at 1-800-437-2437.