| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01256-1 |
| Product Name/Description |
Oxylog Transport Ventilator
Models: 2000plus, 3000 and 3000 plus
ARTG Number: 169507 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Some cases have been reported to Draeger in which the "Poti unplugged" error message was generated. In those cases an audible and visual alarm is generated, the breathing system releases pressure and the ventilation function stops operating. The error message is caused by increased electrical contact resistances of the controllers (setting potentiometers). The increased resistance is caused by an oxide layer that has formed on the controller over a lengthy period of time.
No patient injury has been reported due to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The oxide layer can only form if the controllers are rarely or never moved and according to product monitoring, some users never, or rarely, use the FiO2 controller. As a preventative measure to ensure the resistance taper of the controllers are sufficiently cleaned, Draeger is recommending the following addition to the daily device check:
- Prior to turning on the Oxylog in readiness to conduct the daily device check, the staff member turns each of the controllers (Vt, RR, Pmax and FiO2) to the right and left stop positions (minimum and maximum values) at least ten times each.
- The Oxylog can then be turned on and the onboard device check completed. |
| Contact Information |
03 9244 7248 - Draeger Medical Australia |