A manufacturing error in the ventilator motor assembly may cause mechanical ventilation to fail before or during use, according to an FDA early alert.
RT’s Three Key Takeaways:
- Expanded Device Correction: Draeger is expanding a previous correction to include more Atlan A350 and A350 XL anesthesia workstations due to a manufacturing error in the ventilator motor assembly.
- Risk of Mechanical Failure: The issue may cause the piston ventilator to fail before use or during a procedure, potentially leading to serious consequences such as hypoxia, bradycardia, or cardiac arrest.
- Supervision and Manual Backup: While Draeger plans to replace affected motor assemblies, healthcare providers must use the devices with close supervision and utilize manual ventilation if a failure occurs.
Draeger is expanding an October 2024 correction affecting Draeger Atlan A350 and A350 XL anesthesia workstations that may cause the piston ventilator to fail, according to a May 18 FDA early alert.
The expanded correction now includes additional units of these devices, which are used for anesthetizing adults, children, and neonates during surgical or diagnostic procedures.
According to an early alert from the FDA, the manufacturing error may lead to mechanical ventilation failure. If the error occurs before use, such as during standby or system test modes, mechanical ventilation cannot be started. If the failure occurs during a procedure, the device displays a “Ventilator error!!!” message to alert the user.
While mechanical ventilation may fail, manual ventilation and spontaneous breathing remain possible, and the workstations continue to provide fresh-gas delivery, agent delivery, and monitoring functions, according to the FDA. Healthcare providers may need to manually ventilate patients to prevent injury if a failure occurs.
The use of affected workstations could lead to serious health consequences, including hypoxia, loss of lung recruitment, bradycardia, cardiac arrest, and death. As of May 6, 2026, there have been no reported injuries or deaths associated with this issue, the FDA reported.
Draeger recommended that customers use affected devices only with close, constant supervision until the company can replace the ventilator motor assembly, according to a letter sent to customers. Draeger service representatives will contact customers to arrange dates for the replacement of the affected parts.
The Atlan A350 and A350 XL are designed for automatic and manual ventilation, as well as pressure-supported spontaneous breathing. US customers with questions or reports of adverse reactions can contact Draeger service technical support or the FDA MedWatch program.
