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

Model Number	820 ISO
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ge healthcare (gehc) reported a field modification for reduced concentration delivery of anesthetic agent per 21 cfr 806 on 27-nov-2024.The fda recall number is (recall no.Z-0814-2025).Customers were sent a letter explaining the issue and instructions for inspecting for correct output concentration.Gehc will replace all affected units.Block a: no report of patient involvement.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.
Event or Problem Description
As a result of an inspection that was completed as part of the correction and removal initiated by ge healthcare (gehc) on 27-nov-2024, (recall no.Z-0814-2025) this unit was identified as having an issue with reduced concentration delivery of anesthetic agent.There was no patient involvement.

• 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: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 23088340
• Report Number: 2112667-2025-07375
• Device Sequence Number: 18770731
• Product Code: CAD
• UDI-Device Identifier: 00840682124744
• UDI-Public: (01)00840682124744(11)240321
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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: 820 ISO
• Was Device Available for Evaluation?: Yes
• 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: 08/22/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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
• 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