Correction in Anesthesia Machines: Draeger, Inc. Addresses Issues in Atlan A350 and A350 XL Workstations Linked to Potential Ventilation Malfunction

Correction in Anesthesia Machines: Draeger, Inc. Addresses Issues in Atlan A350 and A350 XL Workstations Linked to Potential Ventilation Malfunction

This recall is aimed at rectifying specific devices, and does not entail their removal from operational settings. The FDA has classified this recall as a high-severity situation. Continuing to use the device without rectification could lead to significant injury or even fatality.

Products Affected

  • Product Names: Atlan A350 and Atlan 350XL anesthesia workstations
  • Unique Device Identifier (UDI)/Model:
  • Atlan A350: 04048675556176/8621500
  • Atlan A350 XL: 04048675556183/8621600
  • Lot/Serial Numbers: Refer to the comprehensive list of affected models

Recommended Actions

Until Draeger, Inc. can replace the motor assembly of the ventilator:

  • Administer these devices under strict and continuous supervision.
  • Switch to manual/spontaneous (Man/Spont) mode for manual ventilation if mechanical support fails.

On October 15, 2024, Draeger, Inc. issued an Urgent Medical Device Correction letter to all impacted clients, informing them that a Draeger representative would reach out to plan for the motor assembly replacement. The letter also included these immediate steps until the correction is executed:

  • Operate devices with constant supervision (according to the Instructions for Use)
  • In case of mechanical ventilation failure:
    • Switch to Man/Spont mode for manual ventilation as necessary.
    • Observe the patient’s oxygenation closely, as any brief interruption in ventilation may lead to harm.
  • Optionally, lower the alarm priority of “Ventilator error!!!” to “ALARM RESET” after entering Man/Spont mode.
  • Ensure all users of the Draeger Atlan and relevant personnel in the healthcare facility are aware of this communication.
  • Complete and send back the Medical Device Correction Response Form included with the letter, acknowledging receipt of the information.
  • Disseminate the notice to any third parties who may have received these machines.

Reason for Adjustment

The correction for Atlan A350 and A350 XL anesthesia stations from Draeger, Inc. stems from a manufacturing flaw that could lead to the piston ventilator failing either before or during operation.

Using the impacted devices risks severe health complications, including hypoxia, lung recruitment impairment, bradycardia, cardiac arrest, and death.

Currently, there have been no reported incidents of injury or death associated with this issue.

Intended Device Use

The Atlan A350 and A350 XL anesthesia workstations are designed to anesthetize patients of various ages, including adults, children, and neonates, providing both automatic and manual ventilation alongside pressure-supported spontaneous breathing and standard breathing. They are employed for inhalational anesthesia during surgical procedures.

Contact Details

For U.S.-based customers seeking further information regarding this recall, they should reach out to Draeger, Inc. Service Technical Support at 1-800-437-2437 (select option 2, then 2, and again 2).

Complete List of Affected Devices

Further FDA Resources

  • FDA’s Enforcement Report
  • Medical Device Recall Database Entries:

Unique Device Identifier (UDI)

The unique device identifier (UDI) serves to pinpoint individual medical devices sold within the United States from manufacturing through distribution to patient application. This identifier ensures more precise reporting, assessment, and analysis of adverse event reports, facilitating the identification and swift rectification of issues.

Reporting Issues

Healthcare professionals and consumers are encouraged to report any adverse reactions or quality concerns regarding these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.