Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event Description
Complainant alleged that while attempting to treat a (b)(6) female patient, who had a stroke, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that the clinician performed cpr to continue treating the patient.Complainant indicated that the patient subsequently expired.
Manufacturer Narrative
Zoll medical corporation representative evaluated the device and the device performed to specification.During review of the activity logs concluded that the device properly identified and recognized the pads, but did not display the signal on the screen due to pads view not being selected.Analysis of reports of this type has not identified an increase in trend.