The customer's complaint was confirmed during in-vitro testing and during the review of in-vivo data.During the 37 days the sensor was used, it triggered sensor check alarms from the beginning till the explant.As revealed by the qc data plot, noise in all on and off channels caused the sensor to trigger those alerts (ec 34).As part of resolution, a return material authorization (rma) was issued for sensor replacement.No further resolution was found necessary for this complaint.D9.Device available for evaluation? yes, 15 july 2022.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 628.H6.Investigation conclusions updated to 44.
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