MalfunctionIYN
ACUSON SC2000 ULTRASOUND SYSTEM
Received May 19, 2026 · Event occurred May 7, 2026
Report 3023245-2026-00037 · MDR key 25219678
Device
Product problems
- Operating System Becomes Nonfunctional
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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).
Description of Event or Problem
DURING A CARDIAC ELECTROPHYSIOLOGY INTERVENTION EXAM WITH THE ACUSON SC2000, THE USER REPORTED BLOCKAGE OF THE SYSTEM. THIS AFFECTED THE CONTINUATION OF THE EXAM, CAUSING THE USER TO REBOOT SEVERAL TIMES IN ORDER TO COMPLETE THE EXAM. THE PATIENT WAS SEDATED AND THIS APPEARS TO HAVE LED TO A DELAY. THERE WAS NO INJURY.
Remedial action
- Repair