MalfunctionCAD
TEC 6 PLUS
Received Jun 9, 2026 · Event occurred May 16, 2026
Report 2112667-2026-03800 · MDR key 25448854
Device
Product problems
- Output below Specifications
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A GE HEALTHCARE¿S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO REPAIR INFORMATION AVAILABLE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. D4 PRIMARY UDI NUMBER: THIS DEVICE WAS NOT MANUFACTURED FOR SALE IN THE USA AND THEREFORE A USA UDI IS NOT AVAILABLE . 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% FROM THE SETTING. THERE WAS NO PATIENT INVOLVEMENT.