Complainant alleged that while defibrillating a patient (age & gender unknown), they observed a spark from the device, then after removing the electrode pads, burns were found on the patient.The customer was unable to provide what degree burn the patient received.Patient sustained burnmarks.
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The device and electrode pads were returned to zoll medical corporation and the customer report was not confirmed or observed.The device was put through extensive testing which included bench handling, energy output testing, and patient impedance calibration without introducing a high impedance condition that would be consistent with the report.Evaluation of the electrodes showed some evidence of arching on the conductive plate of the front pad, however, the back pad had very faint arching at the corners of the conductive gel.Visual inspection found several strands of human hairs mostly on the front pad.No pictures of the reported burn were provided.The evidence is consistent with poor coupling between the patient and the pads.Electrode labeling states the importance of good placement on the patient and provides instruction for proper electrode application technique.Patient burns can be associated outcome with defibrillation events and is identified in labeling as an executed risk.Analysis for reports of this type has not identified an increase in trend.
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