| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-01398-1 |
| Product Name/Description |
CARESCAPE R860 Inspiratory Safety Guard
Product Numbers: 2066713-001(single pack) and 2083208-001 (10 pack)
Lot Numbers: 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129 and 18/00130
ARTG Number: 108358
(GE Healthcare Australia Pty Ltd- Ventilator, adult) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/10/2018 |
| Responsible Entity |
|
| Reason/Issue |
Utilised on only the CARESCAPE R860, the 2066713 Inspiratory Safety Guard (ISG) is a Bi-directional, pleated filter which protects the ventilator inspiratory free breathing path from reverse flow cross contamination. Reverse flow can come from sudden breathing circuit over pressure relieved through the safety relief valve. A patient asynchronous cough or circuit tubing kinks are also example of potential reverse flow through the inspiratory path for the prevention of barotrauma. The component defect is only related the ISG 15mm female connection port. It has been determined the 15mm port is significantly oversized not meeting the ISO conical taper connection standard.
The ventilator ISG may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.
There have been no reported injuries in Australia as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are asked to inspect stock for affected lot numbers.
Customers may continue to use ventilators with the ISG outlet if the 15mm female conical connector is inspected for a secure fit in the location indicated in the customer letter. In order to use the incorrect ISG, customers will need to use an adapter to ensure a pneumatic seal. If an adapter is not available, the ISG cannot be used for the 15mm connection. If customers have any incorrect ISGs, return to GE Healthcare or destroy on site. ISGs still remaining in original packaging with affected lot codes should be returned to GE Healthcare or destroyed on site.
GE Healthcare will replace all affected products at no cost to customers.
This action has been superseeded by RC-2019-RN-00285-1. |
| Contact Information |
02 9846 4000 - GE Healthcare Customer Service |