Complainant alleged that while attempting to cardiovert a (b)(6) year-old male patient, when the device delivered the selected energy, a loud pop/bang noise was heard.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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Zoll medical corporation evaluated the device and the electrodes and the device performed to specification.The device was recertified and returned to the customer.The device was put through extensive testing including full functionality testing without duplicating any malfunction to the device.An internal inspection resulted in no findings.The electrode pads that were used during the event were returned stuck to a trash bag and were compromised but did pass continuity testing.The electrode pads were separated but damage occurred.There are signs of hair and the electrodes were received in a compromised state, stuck to the inside of a trash bag.They were removed, but not without damage to the pads foam.There is evidence of a burn as there is a scorch mark on the tin when the gel is rolled back.The evidence provided by the electrodes supports coupling issues but does not provide enough evidence to understand where the poor coupling manifested.Review of the device log showed the shock event with an increased defib impedance which indicates possible poor coupling between the electrodes and patient.The log review also showed occurrences of check pads/poor pad contact occurring immediately after the shock was delivered, then it toggled back to defib pad short, and back to check pads/poor pad contact.This indicates a possible coupling issue between the electrodes and patient.The coupling issue could be caused by poor patient preparation or application/placement of the electrodes.This report has been attributed to poor coupling of the electrode pads to the patient's skin.Analysis of reports of this type has not identified an increase in trend.
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