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.
Authorities have posted several medical device safety alerts concerning Hamilton Medical AG HAMILTON-C1/T1/MR1 Ventilators / Spare part for ventilator [Product Codes: 161001, 161006, 161009, 161010, MSP161502/12, MSP161339/02] [HKMD No.: 170303 and 200322].
According to authorities, a degrading capacitor on the control board might leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor might lose its function. The primary function of this capacitor is to provide energy to store “Realtime Clock” information in case of total loss of power (external AC supply and battery) for example during storage. As a result of the short circuit, affected HAMILTON-C1/T1/MR1 ventilators might switch to the “Ambient State.” In case of “Ambient State”, active ventilation is no longer provided to the patient. The device is constantly alarming audibly and visually. A loss of “Realtime Clock” information does not have any severe consequence. This situation can only occur during startup of the ventilator. The “Realtime Clock” information needs to be set.
For further information, please visit
國家藥品監督管理局 (NMPA): https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhzj/20230808141012136.html
The Australian Therapeutic Goods Administration (TGA): https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00707-1
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA):
https://mhra-gov.filecamp.com/s/d/5jz15jcv1v3f7Nsz
The United States Food and Drug Administration (FDA):
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92873
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 Aug 2023
Updated on 22 Sep 2023