The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has posted a medical device safety alert concerning Efficia Combined Cable manufactured by Philips. The affected devices are identified as the following:
During use of Efficia Combined Cable/Leadsets, 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. During defibrillation, there is also a possibility of an unintentional electrical shock hazard to the patient and/or clinician. For the patient, this hazard may be present if the Efficia Combined Cable/Leadset remains connected to the electrodes on the patient during the delivery of therapy. For the clinician, this hazard may be present if the clinician is touching the cable during defibrillation.
The manufacturer advised users that the affected cables can continue to be used for monitoring until replacement cables are received. Should a patient require defibrillation or synchronized cardioversion, disconnect the Efficia Combined Cable/Leadset from the electrodes on the patient prior to the delivery of therapy.
Product replacement is on-going.
For details, please refer to the following link:
https://mhra-gov.filecamp.com/s/ZRbRM2S5TK6m499b/d
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 5 February 2020