Device evaluation identified that the cable was ripped and the top and bottom cases were cracked.The belt knob, side screw covers, top screw covers, led lens, top cover and bottom cover were replaced.The device was tested and passed all tests.The root cause for the ripped cable and cracked cases is most likely due to being dropped.This type of event will continue to be monitored.Subsequent to the initial mdr, additional review of the hhe-2019-01 and hhe-2019-02 assessments have been conducted.The health care professional has concluded all fetal transducer products in relation to the resulted recall for both hhe's provided, do not qualify as reportable incidences; therefore, this malfunction should not have been submitted.
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