| TGA Action ID |
RC-2026-RN-00337-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Anaesthesia System – Atlan Family
Atlan A350
Model Number: 8621500
Atlan A100
Model Number: 8621100
Multiple Serial Numbers |
| ARTG Number |
317405 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
This Product Correction is an extension to RC-2024-RN-00886-1, that was published in September 2024. At the time, Draeger had become aware of cases in which the Atlan anaesthesia workstations either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Investigations revealed that the cases are due to an error in the motor electronics (encoder), which was caused by a temporary deviation within the ESD protection measures during the assembly process.
In the course of continuous market monitoring, Draeger has determined that further devices need to be included in the market action.
To date, no reports of patient injury has been received. No other Draeger anaesthesia machines are affected. |
| Instructions for Customers/Users |
A Draeger Service team member will contact customers to replace the motor to correct the problems.
Customers can continue to use the device following the IFU and information outlined in the Customer Letter.
- If the mechanical ventilation fails, use Man/Spon ventilation mode to ventilate the patient manually as needed.
- If necessary, downgrade the alarm priority of the "Ventilator error!!!" alarm with "ALARM RESET".
The failure mode/alarm is described in the Atlan Instructions for Use, including advice on how to continue with manual ventilation.
This action has been closed out on 05/11/2026 |
| Action Commencement Date |
6/05/2026 |
| Responsible Entity |
|
| Contact Information |
1800 372 437 - Draeger Australia |