MalfunctionCAD
TEC 6 PLUS
Received Jun 11, 2026 · Event occurred May 13, 2026
Report 2112667-2026-03829 · MDR key 25468403
Device
Generic name
Vaporizer
Manufacturer
Datex-ohmeda, Inc.Model number
VAP DES 120V JACatalog number
NA
Lot number
NA
Product problems
- 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 DELIVERY LESS THAN 20% FROM THE SETTING DURING A CASE. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
THE CUSTOMER DECLINED GEHC SERVICE. NO REPAIR INFORMATION AVAILABLE. BLOCK A: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. 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.