MalfunctionIYN
ACUSON SC2000 ULTRASOUND SYSTEM
Received May 19, 2026 · Event occurred Mar 23, 2026
Report 3023245-2026-00036 · MDR key 25218877
Device
Product problems
- Loss of Data
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING A STRESS-ECHO EXAM WITH THE ACUSON SC2000, THE USER WAS UNABLE TO SAVE THE EXAM IMAGES. THE PATIENT WAS RE-EXAMINED ON A DIFFERENT SYSTEM. THE DATA LOSS RESULTED IN A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO INJURY REPORTED.
Additional Manufacturer Narrative
AN INVESTIGATION IS ONGOING AT SIEMENS HEALTHINEERS TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. THE REPORT WILL BE SUPPLEMENTED AFTER THE INVESTIGATION IS COMPLETED. REFERENCE #: (B)(4).