| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00127-1 |
| Product Name/Description |
Philips Anaesthesia Machines IntelliSave AX700, Dameca MRI 508, Siesta i Whispa, Siesta iTS & Siesta Breasy
IntelliSave AX700
Product Numbers: 866205/10623-00
Dameca MRI 508
Product Numbers: 866203/10651MRI-00
Siesta i Whispa
Product Numbers: 866202/10651-00
Siesta iTS
Product Numbers: 866163/10653-00
Siesta Breasy
Product Numbers: 866204/10652-00
All serial numbers affected
ARTG Number: 176848 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
If the patient is connected to the anaesthesia machine in a volume controlled ventilation mode, and attempts a large spontaneous breath, it is possible for the patient to create a high negative airway pressure, around the same time as a volume controlled breath (mandatory breath).This pressure will be limited by the mechanical Negative Pressure Limiter (NPL) valve. The NPL valve opens if the patient generates a negative pressure of -5 and -7.5 cmH20 (hPa). This opening pressure of the NPL valve is defined at an inspiratory flow rate of 3.5-4.5 L/min. If the patient creates a higher flow rate than 4.5 L/min, the NPL valve will continue to function but due to the resistance of the flow and time taken to reach the patient, the airway pressure may decrease further. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is providing an updated addendum (Part Number 453564509701 56 052014) to the IFU and recommendation that "If the patient is breathing spontaneously, support ventilation modes (VSV, PSV) could be considered". This action has been closed-out on 08/08/2016. |
| Contact Information |
02 9975 5755 - Device Technologies |