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.
Medical device manufacturer, Maquet Critical Care AB, has issued a medical device safety alert concerning its Servo-n ventilator [Item number: 6688600, 6888011] [HKMD numbers: 230383].
The manufacturer is informed users about a limitation of the intended performance of Servo-n during high frequency oscillatory ventilation (HFOV) when using the Fisher & Paykel neonatal circuit (950N81) and the humidifier FP950.
The manufacturer discovered that the use of a relatively small endotracheal (ET) tube in relation to body weight and in combination with the Fisher & Paykel neonatal circuit that is used with the FP950 humidifier limits the delivered Pampl and therefore reduces the delivered VThf.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Jan 2024