TEC
Received Apr 17, 2026 · Event occurred Mar 23, 2026
Report 2112667-2026-02599 · MDR key 24915698
Device
Generic name
Vaporizer
Manufacturer
Datex-ohmeda, Inc.Model number
6 PLUS VAPORIZORCatalog number
NA
Lot number
NA
Product problems
- Output above Specifications
- Output below Specifications
Patient
NA · Unknown
- 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: NO UDI AVAILABLE AS DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE. 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 GREATER THAN 30% FROM THE SETTING. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE CUSTOMER DECLINED SERVICE. NO REPAIR INFORMATION AVAILABLE.