BCI 8401Recalls & reported problems
Icu Medical, Inc. · Class 2
Quick summary
This ICU Medical BCI 8401 carbon-dioxide analyzer measures breathing gases. Reports mostly describe alarm, screen, power and calibration problems, such as dim unreadable screens, failure to power up, and sensor or calibration errors. There are 100 reports that mention its identifier, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 100
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 10610586036781), received between Jun 29, 2018 and May 1, 2025 — classified as 100 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (22 reports).
1 other recall cover devices cleared under the same FDA submission (K991086); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Alarm System22
- Display or Visual Feedback Problem12
- Power Problem9
- Display Difficult to Read8
- Calibration Problem6
- Failure to Power Up6
- Unable to Obtain Readings5
- Low Readings4
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- No Information14
- No Known Impact Or Consequence To Patient14
- Insufficient Information12
- No Patient Involvement6
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Failure to Recalibrate; Failure to Recalibrate
IT WAS REPORTED THAT DEVICE FAILED GAS CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942480 ↗MalfunctionMar 31, 2025Low Readings; Low Readings
CORRECTION: THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21734554 ↗MalfunctionJan 9, 2025Output below Specifications; Output below Specifications
IT WAS REPORTED THAT THE MONITORING DEVICE HAD A "LOW O2 UNSTABLE" ERROR. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21118046 ↗MalfunctionJan 3, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE MONITORING DEVICE HAD AN ERROR WITH THE CO2 SENSOR. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21069284 ↗MalfunctionJun 4, 2024Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE ETCO2 DEVICE SCREEN WAS SO DIM IT WAS NO LONGER READABLE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19460109 ↗MalfunctionJun 4, 2024Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE ETCO2 DEVICE SCREEN WAS SO DIM IT WAS NO LONGER READABLE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19460107 ↗MalfunctionSep 28, 2023Unstable; Inaccurate Delivery; Unstable; Inaccurate Delivery
IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT, THE DEVICE HAD HIGH OXYGEN AND WAS "UNSTABLE". THE DEVICE WAS TRIED SEVERAL TIMES. THROUGH TECH SUPPORT THE ISSUE WAS DISCOVERED TO BE RELATED TO THE FLOW METER CHECK OF THE CO2 PUMP. IT SHOULD BE 100 TO 140 ML/MIN. THE CUSTOMER FOUND THE FLOW WAS LESS THEN 100ML. NO HARM OR ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17839495 ↗MalfunctionAug 29, 2023Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE DEVICE WOULD NOT REGISTER A READING. PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17646390 ↗MalfunctionApr 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
IT WAS REPORTED THAT THE DEVICE HAD A LOW READING AND NOT ACCURATE, NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16741952 ↗MalfunctionMar 21, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THERE WAS BLANK SCREEN. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 16587610 ↗MalfunctionSep 17, 2022High Readings; High Readings
IT WAS REPORTED THAT THE ETCO2 IS READING IN THE 90'S. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15442969 ↗MalfunctionSep 14, 2022Low Readings; Low Readings
IT WAS REPORTED THAT THE DEVICE READINGS WERE LOW. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15422671 ↗MalfunctionSep 14, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THE DEVICE FAILED CO2 CALIBRATION, CO2 SENSOR MALFUNCTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15422664 ↗MalfunctionSep 13, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT CO2 WAS READING HIGH ON THE DISPLAY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15409643 ↗MalfunctionSep 13, 2022Gas Output Problem; Gas Output Problem
IT WAS REPORTED THAT THERE WAS HIGH CO2, UNSTABLE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15409636 ↗MalfunctionSep 12, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE ALARMED AT 76 MMHG (MILLIMETERS OF MERCURY). NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15402549 ↗MalfunctionSep 1, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE ALARMED OCCLUSION CONSTANTLY AND NO OCCLUSION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15337817 ↗MalfunctionSep 1, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THERE WAS AN OCCLUSION ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15337667 ↗MalfunctionSep 1, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THERE WAS AN OCCLUSION ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15336093 ↗MalfunctionSep 1, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE WAS SHOWING OCCLUSION CONSTANT ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15334279 ↗MalfunctionSep 1, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THERE WAS AN OCCLUSION MESSAGE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15334219 ↗MalfunctionSep 1, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT AN ERROR OCCLUSION WAS FOUND UPON TESTING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15334217 ↗MalfunctionSep 1, 2022False Alarm; False Alarm
IT WAS REPORTED THAT DEVICE KEEPS SAYING OCCLUSION BUT NO OCCLUSION WAS FOUND. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15334205 ↗MalfunctionSep 1, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT AN ERROR OCCLUSION WAS FOUND UPON TESTING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15334169 ↗MalfunctionSep 1, 2022Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow
IT WAS REPORTED THAT THE MONITOR READS CONTINUOUS OCCLUSION AND WAS UNABLE TO OBTAIN END TIDAL READING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15334166 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K991086. One submission often covers many models, so check the product and lot details in each record.
- Z-0920-2010 · Jan 15, 2010 · Terminated8400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main St, Westfield, PA 16950) for its battery charger 330.
Other ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE devices
- Alaris 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall2 deaths8,444 reports
- Alaris 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1 recall607 reports
- BD Alaris™ ETCO2 Module, Model 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE485 reports
- BD Alaris™ ETCO2 Module, Model 8300Carefusion 303, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE471 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.