The device was returned to zoll medical (b)(6) and the device passed all testing, was recertified and returned to the customer.Review of the clinical data showed no signs of a clinical event were seen on the reported event date.However, a suspected event date of (b)(6)2019 did log error messages that display when the device does not detect a valid impedance to indicate the electrode pads are connected to a patient.There are other possible scenarios besides a device malfunction that could contribute to these types of error codes such as the pads are not connected to the patient, the multi-function cable is not attached to the electrode pads or to the device.The electrode pads used were not returned as part of this investigation.Analysis of reports of this type has not identified an increase in trend.
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