The device was not returned to zoll medical corporation for evaluation.Instead the clinical data file was provided.Review of the clinical data file shows synchronized cardioversion was used correctly, the r waves were identified and a single sync cardioversion event was successful.Some of the r waves had high peaks that "touched" the sync marker, but the sync marker was present the entire time once the sync function was enabled leading up the shock.The log confirms that the ecg trace amplitude is visibly lower after the shock, however, this can be resolved by using the lead and size buttons to yield the most consistent sync marker pattern.When the amplitude of the ecg signal increases to above approximately 0x5 volts, the hr value is displayed and sync markers detected.The cause of the signal drop cannot be confirmed on log review, however it doesn't indicate a device malfunction.No trend is associated with reports of this type.
|