| TGA Action ID |
RC-2026-RN-00236-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Giraffe and Panda warmer with Integrated Resuscitation System (iRes) and Giraffe Stand-alone Infant Resuscitation System
Product Codes: 2082663-001, M1241424, M1118179, M1112198 |
| ARTG Number |
305540, 305541 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
GE HealthCare has initiated an investigation following a complaint in Australia that a patient in a Giraffe infant warmer with an integrated resuscitation system (iRes) did not receive the oxygen concentration as set by the clinician on the oxygen blender. GE HealthCare inspected this device at the customer site and observed that the blender control knob was loose. This may have resulted in inaccurate oxygen delivery to the patient.
The patient was moved to an alternate warmer and no patient injury was reported.
Following a safety notice by New South Wales Health related to this complaint, GE HealthCare has received 14 reports of inaccurate oxygen delivery. To date, GE HealthCare has not received any reports of patient injuries related to this matter. |
| Instructions for Customers/Users |
At this time, customers can continue to use their device by following the instructions in the User Manuals, including all pre-use checkout instructions and warnings.
This includes ensuring that all pre-use checkout procedures are correctly completed before each patient use. If a step fails, do not use the device. Oxygen concentration should be verified with an independent oxygen analyser.
If customers have any concerns with the functionality of the oxygen blender, they should contact GE HealthCare immediately.
This action has been closed out on 02/07/2026 |
| Action Commencement Date |
31/03/2026 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE Healthcare |