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 United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Datex-Ohmeda, Inc. Giraffe Warmers and Panda iRes Warmers [HKMD No.: 190384].
According to the MHRA, the manufacturer has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there’s the potential for leakage current to exceed IEC 60601 limits. In the unlikely scenario that this occurs, it could potentially lead to adverse impact to the user or patient.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/uVLFMxnvQz9ipALK
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 05 Sep 2024