VAPOR 2000
Received Jun 29, 2026 · Event occurred May 25, 2026
Report 9611500-2026-00325 · MDR key 25650427
Device
Product problems
- Leak/Splash
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION HAS JUST STARTED, RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THE ANESTHETIC AGENT SPRAYED OUT OF THE VAPORIZER DURING AN OPERATOR ATTEMPT TO FILL IT UP. AS PER REPORT, THE OPERATOR WAS NOT EXPOSED TO THE SUBSTANCE. REMARK: THE PARTICULAR AGENT INTENDED FOR USE WITH THIS DEVICE HAS A BOILING POINT OF 58°C / 136.4°F - IT SHOULD THUS NOT SPRAY OUT OF THE VAPORIZER AT ROOM TEMPERATURE. AT THE MOMENT, THE MANUFACTURER CANNOT EXCLUDE THE PRESENCE OF A MALFUNCTION OR USE ERROR AND THUS, THIS REPORT IS FILED IN ABUNDANCE OF CAUTION. THE DEVICE HAS NO UDI AS AN UDI WAS NOT REQUIRED AT THE TIME THE DEVICE WAS MANUFACTURED.