Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00168-1 |
Product Name/Description |
Oxylog Transport Ventilator
Models: Oxylog 3000plus and Oxylog 2000plus
Serial Numbers: ASEJ-0138, ASEK-0011
ARTG Number: 169507 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
18/02/2014 |
Responsible Entity |
|
Reason/Issue |
The manufacturer has received reports of devices displaying the error message “Poti unplugged”.
The investigation has revealed that a limited batch of Control Panel PCBs - onto which the potentiometer for setting the ventilation parameters is soldered, is faulty. This can result in the contact to the respective potentiometer being interrupted. The device then discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged. If this error occurs the user must immediately commence ventilation using an independent ventilator (manual ventilation bag) as specified in the Instructions for Use Manual. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Draeger are recommending users commence manual ventilation as specified in the Instructions for Use (IFU) if the error occurs. Draeger will be contacting all affected users to organise the correction of the affected devices. |
Contact Information |
1800 800 327 - Draeger Medical Australia Customer Service |