Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Datex-Ohmeda, Inc. (GE Healthcare Australia Pty Ltd) Giraffe OmniBed and Giraffe OmniBed Carestation [HKMD number: 190110].
According to the TGA, the manufacturer has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification, causing the doors to become loose. If the doors become loose, the system activates a high priority alarm, and the canopy movement will stop. Continuing to force the canopy to move may damage the canopy and, in rare cases, might cause the heater door to fall, potentially causing injury to the patient.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00828-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Sep 2024