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 Pads Adapter Cable, when used with either the Efficia DFM100 or HeartStart Intrepid Monitor/Defibrillator [HKMD No.: 160007].
The manufacturer is informing users that Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators are at risk of failed ECG monitoring, defibrillation, synchronized cardioversion, or transcutaneous pacing when using the affected Efficia Pads Adapter Cables. There are no reliable indications that predict when such an episode may occur.
According to the manufacturer, due to wear and tear from flexing of the Pads Adapter Cable, Efficia Pads Adapter Cables may unexpectedly fail causing Efficia DFM100 and HeartStart Intrepid Monitor/defibrillator devices to be unable to perform ECG monitoring, defibrillation, synchronized cardioversion, or transcutaneous pacing.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 Jan 2023