MalfunctionCAD
TEC
Received May 29, 2026 · Event occurred May 1, 2026
Report 2112667-2026-03588 · MDR key 25334179
Device
Product problems
- Inaccurate Delivery
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE REPORTED EVENT WAS CONFIRMED. BUT THE END USER SCRAPPED THE UNIT. THERE WAS NO GE HEALTHCARE REPAIR.
Additional Manufacturer Narrative
GE HEALTHCARE¿S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AGENT DELIVERY LESS THAT -20%. THERE WAS NO PATIENT INVOLVEMENT.