| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00488-1 |
| Product Name/Description |
Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV & E-CAiOVX (used with CARESCAPE Monitors B850 and B650, Avance and Aisys Anesthesia Carestations, Engstrom Respiratory Carestation, or S/5 Anesthesia and Critical Care Monitors)
Affected serial number range # 6704120 - 6778756
ARTG Number: 166230 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue due to gas sampling pump failure associated with the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. If this issue occurs, the monitor will show an alarm note on monitor screen of either "Low gas sample flow" or "Check sample gas out". |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare will implement a correction for the affected modules. If the monitor is showing an alarm of “Low gas sample flow” or “Check sample gas out”, users are advised to check the following before continued use:
1. Check the water trap is not full or occluded. If full or occluded, empty/change the water trap.
2. Check gas sampling adapter at patient airway is not occluded.
3. Check sample line is not occluded. If occluded, change new gas sampling line.
4. Check gas exhaust outlet is not occluded. Ensure there is no blockage preventing the sample gas out flow to scavenging.
If the above actions do not remove the alarm message(s), it may be due to the issue described above. Users are advised to remove the equipment from use and contact technical support or local service representative. This action has been closed-out on 02/02/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |