It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with carto® 3 system and a current leakage error 7 and noise on all electrocardiogram (ecg) signals occurred.Earlier in the procedure there was a temperature issue which resolved when the catheter was exchanged.After that, a current leakage error 7 displayed on the carto.In addition to the current leakage error, there was a signal interference on the intracardiac and body surface channels, as well as the carto and recording system.There were no ecg signals available for the physician to monitor the patient¿s heart rhythm.The patient interface unity was restarted without being connected to the cable and catheter, and the issue resolved.The case continued without further incident or patient harm.Temperature issue is not reportable, as user selected cut-off was never exceeded.However, since the physician had no ecg signal available to monitor the patient¿s heart rhythm during the signal interference issue, this event has been assessed as a reportable malfunction.
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