MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VAPOR 2000; ANESTHESIA UNIT VAPORIZERS

Model Number	M35054
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started, results will be provided in a follow-up report.
Event or Problem Description
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.

• Brand Name: VAPOR 2000
• Common Device Name: ANESTHESIA UNIT VAPORIZERS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 25650431
• Report Number: 9611500-2026-00326
• Device Sequence Number: 5877847
• Product Code: CAD
• UDI-Device Identifier: 04048675228059
• UDI-Public: (01)04048675228059(11)150205(93)M35054-27
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K971923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M35054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown