| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00095-1 |
| Product Name/Description |
Acutronic Fabian HFO (High Frequency Oscillation) Ventilators , software versions below GUI 3.0.2.7
PN 7200
All serial numbers supplied
ARTG Number: 185053 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Medical Technologies is informing end users of an extremely rare software problem. The problem is withinthe embedded software of the fabian HFO. Fabian HFO devices may as a symptom exhibit a halting user interface (touchscreen and/or hard keys). If this happens, it will no longer be possible to adjust the parameter settings. The current ventilation parameters are maintained and there is no interruption to ventilation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In the event of this problem occurring, it is recommended to transfer the patient to an alternative ventilator. The fabian HFO can continue to be used ONLY in the event where no other ventilator is available in the facility as the single fault condition alarms in the event of a halting user interface, alerting the operator. All fabian HFO ventilators will be updated with software GUI 3.0.2.7 made available by Acutronic. This will prevent the described problem. In addition, Acutronic software has a new watchdog implementation that monitors the state of the serial communication. A failsafe mechanism triggered by watchdog will prevent further similar occurrences from happening. This action has been closed-out on 15/07/2016. |
| Contact Information |
08 9340 3500 - Medical Technologies |