| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00158-1 |
| Product Name/Description |
Dräger Fabius Anaesthesia Machines
Devices : Fabius Plus XL, Fabius Tiro, Fabius Tiro, Fabius GS Premium, Fabius Plus XL
Serial Numbers :ASKM-0047, ASKH-0027, ASKH-0168, ASKH-0140, ASKM-0246
ARTG Number: 104223
(Draeger Australia - Anaesthesia system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Dräger has become aware of one case where the automatic Ventilation failed during the operation of a Fabius unit. This was due to the motor moving beyond the upper position and thereby damaging the Ventilator cover. Ventilation of the patient could reportedly be continued by means of the ManSpont mode and a manual resuscitator.
No serious injury has been reported to date.
As a precaution Drager will be updating relevant units |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Drager is advising they are currently producing replacement motors for the potentially affected devices. Dräger Service have ordered the replacement motor(s) and on receipt of the part from Germany, will contact the Biomedical Engineering team to arrange free of charge, the installation and testing of the replacement motor.
In the interim, users may continue to operate the anaesthesia device with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for Use.
This action has been closed out on the 15/11/2018. |
| Contact Information |
03 9244 7248 - Customer Service Support |