MalfunctionCAD
TEC 7
Received Dec 19, 2025 · Event occurred Nov 21, 2025
Report 2112667-2025-09839 · MDR key 23848511
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
- Output below Specifications
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Additional Manufacturer Narrative
THE CUSTOMER DECLINED GEHC SERVICE. NO REPAIR INFORMATION AVAILABLE. BLOCK 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.