MAUDE Adverse Event Report: DATEX-OHMEDA, INC. TEC 7; VAPORIZER

Model Number	ISO 5% EASY-FIL EN
Medical Device Problem Codes	Output below Specifications (3004); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a malfunction resulting in insufficient agent delivery less than -20% of setting.There was no patient injury.
Additional Manufacturer Narrative
Ge healthcare 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.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.
Additional Manufacturer Narrative
Additional information was received that there was no reportable malfunction.

• Brand Name: TEC 7
• 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: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 22056369
• Report Number: 2112667-2025-04222
• Device Sequence Number: 20622187
• Product Code: CAD
• UDI-Device Identifier: 00840682111300
• UDI-Public: (01)00840682111300
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K012924
• 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,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: ISO 5% EASY-FIL EN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2017
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown