MAUDE Adverse Event Report: Datex-Ohmeda, Inc. TEC; Vaporizer

Model Number	850 SEV
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction

• Brand Name: TEC
• Common Device Name: Vaporizer
• Manufacturer (Section D): Datex-Ohmeda, Inc.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): Datex-Ohmeda, Inc.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: michaela moore ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 50952737
• Report Number: 2112667-2026-05944
• Device Sequence Number: 13374840
• Product Code: CAD
• UDI-Device Identifier: 00840682124737
• UDI-Public: (01)00840682124737(11)230906
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K172702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 850 SEV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0814-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown