BCI 1121Recalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30610586038260), received between Jun 12, 2017 and Jun 12, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
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
- Material Integrity Problem1
Patient problems
- No Information1
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2017Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE WIRE OF A BCI® CANNULA SAMPLE LINE BECAME EXPOSED DURING USE. IT WAS REPORTED THAT A "SERIOUS ADVERSE EVENT" OCCURRED, HOWEVER, DETAILS OF THE ADVERSE EVENT WERE NOT PROVIDED. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
Patient problems: No Information; Partial thickness (Second Degree) Burn
MAUDE report 6634867 ↗
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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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