Registered internally as a complaint (reference (b)(4)) for further investigation by manufacturer.Complainant did not supply specific details regarding all of patient attributes.(patient age at time of event) and (patient weight) set equal to "0" (zero) in order to provide data entry required by esubmitter software.The electrodes described are manufactured for (b)(4) by a contract manufacturer.The electrodes are supplied to natus by a contract manufacturer.The contract manufacturer reviewed the manufacturing and test records for the lot of electrodes identified and found the manufacturing parameters were all within specification.A separate mdr has been created and submitted for the equipment used, viking select emg system p/n 982a0403 s/n (b)(4) (ref mdr 3010611950-2015-00013).Electro-cautery equipment was in use by the complainant at the same time as the natus device in question.There are known risks associated with such device to device combinations where electrodes can intercept stray radio frequency energy and result in thermal heating.Natus safety information supplied to end users states such interactions exist and warns end users that electrode disconnection may be needed to avoid such interactions (ref natus safety reference guide, label #269-594705).
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