Starting from 1 January 2022, safety alerts related to medical devices listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
Medical device manufacturer, Philips has issued a medical device safety alert concerning its Efficia External Paddles, which are intended to be used with the Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators [HKMD No.: 160007].
The manufacturer is informing users that the Efficia External Paddles may not be properly identified by an Efficia DFM100 or HeartStart Intrepid Monitor/Defibrillator when connected to the device. The device may display an error message reading“Pads/Paddle Type Unknown”. When this occurs, it is accompanied by a menu prompting the user to select a therapy cable type. The message cannot be cleared until the user either selects the cable type, disconnects and reconnects the cable, or restarts the device.
According to manufacturer, if an Efficia DFM100 or HeartStart Intrepid Monitor/Defibrillator is needed for clinical use and experiences these device behaviors, then that could result in a delay of therapy being delivered to a patient.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 Jan 2023