| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00365-1 |
| Product Name/Description |
Philips Dameca Siesta i TS with an EGM software version lower than 4.0.8 / 7.0.8
(Anaesthesia system)
ARTG number: 176848 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
It has been discovered that the touch screen on Dameca Siesta i TS machine may malfunction, resulting in the screen freezing or in some cases turning black during usage. This results in the user not being able to operate the machine using the touch screen, current information is not displayed and settings cannot be modified. The machine will stop automatic ventilation and an alarm will sound and the user needs to initiate manual ventilation by activating the emergency fresh-gas flow function (Emergency O2) on the Siesta i TS and maintaining ventilation by means of the ventilation bag (Manual ventilation).
The highest concern is the potential loss of ventilation and fresh gas flow. If losing ventilation and fresh gas flow, this will result in the need of manual ventilation with external fresh gas flow and emergency equipment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that in cases where automatic ventilation stops, the machine should be restarted (while manually ventilating the patient) and then taken back into normal usage again (return to automatic ventilation and fresh-gas delivery by the electronic gas mixer) after the machine has restarted. Users are also advised to check their existing machine’s version. If EGM software version is lower than 4.0.8/7.0.8 and the problem arises a technician visit will be arranged to upgrade the software. This action has been closed-out on 15/02/2017. |
| Contact Information |
1300 999 323 - Device Technologies |