ULTRASOUND
Received Apr 7, 2026 · Event occurred Oct 1, 2025
Report 3023245-2026-00030 · MDR key 24801244
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SAVE LOGS WERE CAPTURED, PATIENT DE-IDENTIFIED AND PUT ONTO USB. PATIENT IS BEING CALLED BACK FOR A SECONDARY STRESS ECHO SINCE IT IS INCONCLUSIVE.
Description of Event or Problem
ON (B)(6) 8 AM CENTRAL TIME A FULL ECHO WAS PERFORMED AND A REPORT WAS SAVED, WITHOUT ENDING THE EXAM THE SONOGRAPHER THEN WENT INTO STRESS ECHO PROTOCOL (TREADMILL CONTRAST) AND PERFORMED NORMAL REST AND POST IMAGES. MEASUREMENTS WERE MADE ON THE POST STRESS IMAGES FOR EJECTION FRACTION. THE SONOGRAPHER STORED A SECONDARY REPORT THAT INCLUDED THE STRESS POST MEASUREMENTS. THE STUDY WAS ENDED AND SCENT TO PICOM (PACS). ON (B)(6) AM, ONE OF THE PHYSICIANS CALLED SAYING THERE ARE NO STRESS ECHO IMAGES SEEN ONLY THE ORIGINAL FULL ECHO. WHEN I ARRIVED, IT WAS PAST 24 HOURS AND YOU CAN NO LONGER APPEND IMAGES. THE FULL ORIGINAL EXAM WAS SEEN, AND THE POST IMAGES WITH CONTRAST THAT WERE MEASURED FOR EJECTION FRACTION AS WELL AS THE POST STRESS REPORT. HOWEVER, THERE WERE NO STRESS ECHO IMAGES ON THE STUDY. THE IMAGES JUMPED FROM NUMBER 91 TO NUMBER 183 ON THE THUMBNAILS, WITH NOTHING IN BETWEEN.