Portex 650904Recalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10351688419446), received between Mar 14, 2020 and Mar 14, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (5 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash5
Patient problems
- No Patient Involvement5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2020Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED INDICATING THAT THE SEAL TO A SMITHS MEDICAL PORTEX® ADULT ANESTHESIA BREATHING CIRCUIT WAS REPORTED TO BE LEAKING. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: No Patient Involvement
MAUDE report 9832680 ↗MalfunctionMar 14, 2020Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED INDICATING THAT THE SEAL TO A SMITHS MEDICAL PORTEX® ADULT ANESTHESIA BREATHING CIRCUIT WAS REPORTED TO BE LEAKING. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: No Patient Involvement
MAUDE report 9832664 ↗MalfunctionMar 14, 2020Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED INDICATING THAT THE SEAL TO A SMITHS MEDICAL PORTEX® ADULT ANESTHESIA BREATHING CIRCUIT WAS REPORTED TO BE LEAKING. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: No Patient Involvement
MAUDE report 9832658 ↗MalfunctionMar 14, 2020Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED INDICATING THAT THE SEAL TO A SMITHS MEDICAL PORTEX® ADULT ANESTHESIA BREATHING CIRCUIT WAS REPORTED TO BE LEAKING. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: No Patient Involvement
MAUDE report 9832656 ↗MalfunctionMar 14, 2020Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED INDICATING THAT THE SEAL TO A SMITHS MEDICAL PORTEX® ADULT ANESTHESIA BREATHING CIRCUIT WAS REPORTED TO BE LEAKING. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: No Patient Involvement
MAUDE report 9832653 ↗
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- NA GF-210RNihon Kohden Corporation · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE386 reports
- Trilogy IT2110X21BRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls30 reports
- Trilogy Trilogy Evo Ventilator, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls26 reports
- Trilogy Evo Trilogy Evo Ventilator with oxygen blending model, GermanyRespironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls9 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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