Reportedly, post repair, the device has a broken case, loose parts inside or possibly broken crystals.There was no report of patient involvement.No additional is information available.
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The complaint device was returned for evaluation incoming visual inspection found no anomalies; however, loose parts were heard inside.Technical visual inspection found no anomalies.Device evaluation found the ultrasound electrical check failed confirming the reported crystal issue.The report of the cracked case was refuted.There were three crystals that were re-secured.The broken internal components (capacitator, resistors and amps) were replaced.The ultrasound electrical check test was re-ran and passed.The root cause for the loose crystals was most likely due to the adhesive not curing properly and the device may have been dropped.This type of event will continue to be monitored.Device code 1135 removed - correction.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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