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 GE Healthcare Australia Pty Ltd. Giraffe OmniBeds and Giraffe OmniBed Carestation [Carestation Product code: 2082844-001-XXX; Carestation GTIN: 010084068211686221; Bedside panel FRU Kit numbers: 5865384-01 to 5865384-34, 5865385-01 to 5865385-34, 5865386-01 to 5865386-34 and 5865387-01 to 5865387-34] [HKMD No.: 190109, 190110].
According to the TGA, the manufacturer has identified there is the potential that an incorrect type of secondary latch was installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices. For devices that have the incorrect type of secondary latch installed, the north wall can potentially become disengaged when the canopy is raised. There has been no customer complaints of this issue and no patient injuries
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00520-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 Jun 2023