TEC 7 VAP SEV 8% EASY-FIL EN P1Recalls & reported problems
Datex-Ohmeda Inc · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840682111454), received between Sep 8, 2025 and Sep 29, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).
1 other recall cover devices cleared under the same FDA submission (K012924); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Excess Flow or Over-Infusion1
- Output below Specifications1
- Unexpected Therapeutic Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Output below Specifications
It was reported that there was a malfunction resulting in agent delivered less than 20% from setting during pre-use checkout. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931615 ↗MalfunctionSep 12, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AGENT DELIVERED GREATER THAN 30% FROM SETTING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23036301 ↗MalfunctionSep 8, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AGENT DELIVERY IN EXCESS OF THE +30% OF SETTING DURING A CASE. THE CLINICIAN WAS ABLE TO REDUCE THE AMOUNT OF AGENT BEING DELIVERED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22992944 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K012924. One submission often covers many models, so check the product and lot details in each record.
- Z-1198-2018 · Oct 4, 2017 · TerminatedDATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthes
Other VAPORIZER, ANESTHESIA, NON-HEATED devices
- TEC 850 SEVDatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED1 recall2,251 reports
- TEC 850 ISODatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED1 recall184 reports
- TEC 6 PLUS VAP DES 120V ESDatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED1 recall63 reports
- TEC 820 SEVDatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED1 recall59 reports
- TEC 6 PLUS VAP DES 220/240V ENDatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED1 recall48 reports
- TEC 820 ISODatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED1 recall31 reports
- Vapor 2000 M35054Drägerwerk AG & Co. KGaA · Vaporizer, Anesthesia, Non-Heated1 recall8 reports
- Vapor 3000 M36500Drägerwerk AG & Co. KGaA · Vaporizer, Anesthesia, Non-Heated1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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