Medical device manufacturer, Philips Healthcare, has issued a medical device safety alert concerning its Efficia 3/5 ECG Trunk Cable, AAMI/IEC [Part Number: 989803160641; Affected cables were produced from Feb 2014 through Sep 2018].
The manufacturer stated that during use of certain Efficia ECG Trunk Cables, if the patient required electrical energy for defibrillation or cardioversion, it is possible for some of the energy to be diverted away from the patient's thoracic cavity through the ECG cable. This could result in a reduction in defibrillation energy delivered to the patient. In addition, it is possible for the patient to not receive defibrillation therapy as expected. There is no risk of external electrical exposure to the caregiver.
Customers are advised to identify and discontinue use of all affected products. Product replacement is on-going
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Nov 2018