TEC 7
Received Feb 20, 2025 · Event occurred Jan 23, 2025
Report 2112667-2025-01203 · MDR key 21426557
Device
Generic name
Vaporizer
Manufacturer
Datex-ohmeda, Inc.Model number
SEVO 8% EASY-FIL JACatalog number
NA
Lot number
NA
Product problems
- Output below Specifications
- No Apparent Adverse Event
- Output below Specifications
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO REPORTABLE MALFUNCTION.
Additional Manufacturer Narrative
GE HEALTHCARES INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. BLOCK H4:Â DATEÂ OFÂ DEVICEÂ MANUFACTURE YEAR IS 2012. THE MONTHÂ OFÂ MANUFACTURE WAS UNAVAILABLE AT TIMEÂ OFÂ MDR FILING. BLOCK D4: 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 INSUFFICIENT AGENT DELIVERY LESS THAN -20% OF SETTING. THERE WAS NO PATIENT INJURY.