TEC 6 PLUS
Received May 19, 2026 · Event occurred Apr 22, 2026
Report 2112667-2026-03367 · MDR key 25221425
Device
Generic name
Vaporizer
Manufacturer
Datex-ohmeda, Inc.Model number
VAPORIZORCatalog number
NA
Lot number
NA
Product problems
- Output above Specifications
- Output below Specifications
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AGENT DELIVERED MORE THAN 30% FROM SETTING. THERE WAS NO PATIENT INVOLVEMENT.
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: NO UDI AVAILABLE AS DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.
Additional Manufacturer Narrative
THE CUSTOMER DECLINED SERVICE. NO REPAIR INFORMATION AVAILABLE.