| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01617-1 |
| Product Name/Description |
Dräger Oxylog Transport Ventilators - Oxylog 3000 and Oxylog 3000plus
All Serial Numbers
ARTG Number: 169507 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
In Dec 2015, Dräger informed users of an error condition observed with the Oxylog 3000 / Oxylog 3000plus (TGA Ref.: RC-2015-RN-01256-1), where the loss of contact of one of the control knobs generated an error message (previously referred to as "Poti unplugged"). In these cases, acoustical and visual alarms are triggered, the breathing system releases pressure & the ventilation function stops operating. Investigations indicated that the error condition was caused by an oxide layer in the potentiometer. These oxide layers may accumulate over a longer period of time where various factors collude (i.e. if the knobs are moved rarely or never). As communicated previously, a verified remedy is repeated twisting of the knobs that removes the oxide layer. Whilst the remedy of twisting the knob is still considered effective, to reduce the impact of this error condition Dräger has developed new software. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Dräger has developed a new software that reduces the impact of the error condition i.e., software version 1.06 will be introduced for the Oxylog 3000plus and software version 1.23 for Oxylog 3000 respectively. A Dräger engineer will contact affected customers directly to schedule the software upgrade. Whenever a "control knob faulty" condition will occur with a device being equipped with the new software, the device will continue to ventilate with the last valid settings, display for example the values for tidal volume in case of a defective potentiometer for VT and post the corresponding alarm. As reflected in the amended Instructions for Use Manual, users are advised to check the patient’s condition and the ventilation.
This action has been closed out on 18/09/2018 |
| Contact Information |
02 9244 7248 - Draeger Medical Australia |