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 Hamilton Medical AG HAMILTON-C6 Ventilator [PN: 160021; Reference #: CER 101091] [HKMD No.: 200332].
According to the MHRA, there are two potential malfunctions detected following an inspection by the manufacturer. The first malfunction is about safety ventilation can be triggered by switching to an adaptive mode. And the second malfunction is about the display can be restarted by changing the Target Shift setting (only in INTELLiVENT-ASV mode).
For further information, please visit https://mhra-gov.filecamp.com/s/d/C8K9eAn5LiF5YiFO
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Feb 2023