TEC 7
Received Jan 14, 2026 · Event occurred Dec 16, 2025
Report 2112667-2026-00285 · MDR key 24065283
Device
Generic name
Vaporizer
Manufacturer
Datex-ohmeda, Inc.Model number
VAP SEV 8% EASY-FILCatalog number
NA
Lot number
NA
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. A: NO REPORT OF PATIENT INVOLVEMENT. D4. PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. 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 DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.