Complainant alleged that while attempting to defibrillate a patient (age & gender unknown) in cardiac arrest, the device successfully delivered one shock.The device then failed to discharge a second shock.A new set of electrode pads were applied to the patient and the selected energy was delivered.However, on a subsequent shock there was a spark seen from the pads.The electrodes were replaced again to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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Zoll medical united kingdom evaluated the device for the report of unable to discharge and sparked.The device was put through extensive testing including functional testing, defib/pacer stress testing, bench handling, and defib cycling without duplicating any malfunction to the device.The device was recertified and returned to the customer.The log showed the device is charged but is in a defib lead fault state before being able to discharge on the third attempt.A defib lead fault indicates an invalid patient impedance but was ultimately achieved based on the delivery of therapy on the third shock attempt.This third shock to the patient indicated poor coupling which likely led to the spark observed.Poor coupling can be caused by various factors including but not limited to electrode placement, poor patient preparation, or just poor contact between the pad and patient.Poor coupling can lead to air pockets forming between the electrodes and the patient which can cause sparking, burning smell, and pop sound.The x series operator's guide states, 'do not use therapy or ecg electrodes if the gel is dried, separated, torn, or split from the foil; patient burns may result from using such electrodes.Poor adherence and/or air pockets under therapy electrodes can cause arcing and skin burns.' analysis of reports of this type has not identified an increase in trend.
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