| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00886-1 |
| Product Name/Description |
Anaesthesia System – Atlan Family
Atlan A350
Model Number: 8621500
Serial Numbers: ASTB-0192, ASTD-0006, ASTD-0007, ASTD-0111, ASTD-0112, ASTD-0234, ASTE-0138, ASTE-0230, ASTE-0231, ASTE-0232, ASTE-0233
Atlan A100
Model number: 8621100
Serial number: ASTD-0286
ARTG 317405
(Draeger Australia Pty Ltd - Anaesthesia system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
Draeger have 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. This is due to an error in the motor electronics, which was caused by a temporary deviation in the assembly process.
If the problems occur it may be necessary to manually ventilate the patient. To date, no reports of patient injury has been received.
No other Draeger anaesthesia machines are affected. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
A Draeger Service team member will contact customers to replace the motor to correct the problems.
Customer can continue to use the device following the IFU and information in the customer letter.
If the error occurs before use (during standby or system test mode) mechanical ventilation cannot be initiated. To troubleshoot, power down and restart the device and follow the standard fault diagnosis procedure. If the error persists after these steps, remove the device from use.
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 patient injury. With ongoing alarm of the ventilation failure, the Atlan continues to provide the Man/Spon ventilation mode, fresh-gas and agent delivery as well as all monitoring functions without restriction. |
| Contact Information |
1800 372 437 - Draeger Australia |