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

Model Number	850 SEV
Medical Device Problem Codes	Failure to Run on Battery (1466); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a battery failure that could cause loss of mechanical ventilation.There was no patient involvement.
Additional Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The battery was replaced to resolve the issue.Block a: no report of patient involvement.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.
Additional Manufacturer Narrative
This supplemental mdr is being filed to correct the initial mdr which was reported for the incorrect malfunction.This supplemental mdr is being filed to report that the malfunction is associated with recall no.Z-0814-2025, 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.
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 drive; madison WI 53718
• Manufacturer Contact: michaela moore ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 25332849
• Report Number: 2112667-2026-03579
• Device Sequence Number: 9619215
• Product Code: CAD
• UDI-Device Identifier: 00840682124737
• UDI-Public: (01)00840682124737(11)240514
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 05/29/2026

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: 850 SEV
• Device Lot Number: SQBD02843
• 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: 05/22/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• 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