If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The unit was received at the service center and evaluated.Performed service and repair functions as per (b)(4).Attach box label and fms vue final testing, software upgrade was not needed.Replaced left and right side door assy.(missing magnet) to correct issue.Also replaced damaged left door mounting post.Replaced worn fingers on pressure arm housing (preventative maintenance) with tip replacement kit.The unit passed all diagnostic tests, functional tests, and is fully operational.A review of the device history record indicated that this lot of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
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It was reported by the customer that during an unspecified surgical procedure, it was observed that the fms vue pump device was not working properly as it had no suction.There was a five minute delay in the surgical procedure as an identical spare device was used to complete the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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