Retained samples of the concerned lot/batch have been inspected visually.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.No information on the patient, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect, duration of use and details of the use was provided.We have requested further information several times but none was made available after requesting several times for further information on the patient and the procedure using ecg electrodes we have been informed "we can only go with what we have they are not willing to send anymore information." therefore no further conclusion can be drawn and we close the investigation.
|
On november 17th, 2020, we have been informed about an incident with ecg electrodes at an unknown healthcare facility in uk.Skintact electrodes model fsvf01 were used.The complainant reported "the patient attended for consultation and additional pacemaker interrogation.Patient was connected to 4 lead ecg on abbott programmer using skintact ecg electrodes.Upon completion of the device interrogation, cardiac physiologist and patient were unable to remove one of the ecg electrodes from patient's right arm.Consultant attempted but was also unable to remove electrode so suggested we submerged patient's arm in water to loosen adhesive material.Patient's arm was submerged for 5-10 minutes and consultant was able to remove electrode although notably it caused pain and broke the skin on patient's arm." no further details have been disclosed despite repeated requests.
|