The device was received at zoll medical (b)(4) for evaluation.The customer's report was not replicated or confirmed.The device was recertified and returned to the customer.Review of the device activity logs showed that the device was in a lead fault state while attempting to analyze.No valid patient impedance was detected.This likely indicates poor coupling between the electrode pads and the adaptor (adaptor tested without any discrepancies), or poor coupling between the electrode pads and the patient's skin.However, this could not be firmly established as the electrode pads used were not available as part of this investigation.Analysis of reports of this type has not identified an increase in trend.
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