| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-01771-1 |
| Product Name/Description |
Babylog VN500, Evita V300 and Evita V500
Software version SW2.60 and lower.
ARTG 92177 (Draeger Australia Pty Ltd Ventilator, adult)
ARTG 158739 (Draeger Australia Pty Ltd - Ventilator, adult)
ARTG 170141 (Draeger Australia Pty Ltd - Ventilator, intensive care, neonatal/pediatric) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/08/2021 |
| Responsible Entity |
|
| Reason/Issue |
Draeger have become aware of sporadic cases in which the ventilators restarted unintentionally. In the rare reported cases, an error in the data processing of the activated CO2 measurement caused the restart of the ventilation unit. Devices without integrated or with a disabled CO2 measurement function are not affected.
During the restart, the ventilation is temporarily interrupted, and an audible alarm is activated by the auxiliary acoustic alarm system. The breathing system is opened to the ambient air during the restart to potentially allow the patient to breathe spontaneously. Opening the breathing system to ambient causes a loss of ventilation support from the ventilator including PEEP. The ventilation unit is restarted and after approximately 8 seconds automatically resumes ventilation at the identical settings prior to the restart.
There have been no reports of injury in relation to this matter to date. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised, if the information from this Product Defect Correction is considered, the devices can remain in operation. The behaviour can be effectively prevented by not activating the integrated CO2 measurement. If necessary, external CO2 monitoring can be used.
Draeger has started to develop a software correction and global customers will be provided with an updated software version as soon as it becomes available. The release of a corrected software is expected to be available in Q4 of 2021.
If an external CO2 monitoring device is not available, or if the use of the integrated CO2 measurement function is required, customers are advised to inspect your stock and quarantine the impacted device to prevent use, until the software correction has been implemented.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
0459 956 368 - David Gladman (Draeger) |