During imaging with a retcam 3 in (b)(6) , a software anomaly was observed.Under certain user workflows, exam information on the retcam exam review screen was displayed for a patient other than the expected patient.The exam information was correct for the displayed patient.No patient injury was reported.However, there is a remote possibility if this occurs again, the user will not recognize the fact that the displayed patient is not the expected patient which could lead to delayed diagnosis or delayed treatment.The retcam 3 device serial number is (b)(4).The user has been informed to use workflows that will avoid this situation.
|