The complaint device was returned.Device evaluation identified that there was a gap in the casing and the screw post on the bottom case were broken.Additionally, the ultrasound transducer electrical check failed confirming the reported event.The bottom and top cases, and seven piezoelectric crystals were replaced.The parameter tests were performed and all passed.A definitive root cause was unable to be determined.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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