MalfunctionCAD
TEC
Received Jun 9, 2026 · Event occurred May 11, 2026
Report 2112667-2026-03781 · MDR key 25444694
Device
Product problems
- Output below Specifications
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 THAN 20% OF SETTING DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.