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, Medtronic HeartWare, has issued a medical device safety alert concerning its HeartWare Ventricular Assist Device (HVAD) System Battery [HKMD No.: 180485].
The manufacturer is taking actions to address two separate battery issues: 1) a weld nonconformance has been identified within some batteries that can cause the battery to fail to deliver power, 2) an interaction between the battery software configuration and the battery circuit board can cause electrical faults within some batteries.
Batteries are provided with the HVAD System and are used to power the HVAD Controller. If there is an issue with the battery, the controller is designed to provide an alarm indicating when power is not reaching the controller. Electrical issues can cause the battery to stop providing power to the controller or may prevent the battery from properly recharging or holding a charge. If this happens, the HVAD System may malfunction or stop functioning, and this could rapidly lead to serious health consequences.
The affected users should follow the advice listed on the customer letter provided by the manufacturer to lower the risk of experiencing an issue with the HVAD system caused by a battery problem.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 Jun 2022