BCI 8400Recalls & reported problems
Icu Medical, Inc. · Class 2
Quick summary
This ICU Medical BCI 8400 carbon dioxide gas analyzer is a bedside monitor module that measures CO2 levels in a patient's breath. The 35 reports since 2019 mostly describe the unit alarming or refusing to calibrate, blank or cracked screens, units failing to power on, and CO2 readings that came back inaccurate or not at all. No deaths or injuries are described in any report. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10610586036354), received between Jul 18, 2019 and May 15, 2025 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (8 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 System8
- Display or Visual Feedback Problem5
- Incorrect, Inadequate or Imprecise Result or Readings4
- Calibration Problem3
- Incorrect Measurement3
- Defective Device2
- Display Difficult to Read2
- Failure to Power Up2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information8
- No Information4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2025Circuit Failure; Circuit Failure
IT WAS REPORTED THAT IT IS DISPLAYING MESSAGE NEW TIDAL CO2 MODULE, AND CRACKING IN THE PLASTIC SCREEN MODULE. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22031707 ↗MalfunctionJun 11, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAS HIGH CO2 SENSOR ERROR ALARM. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19511089 ↗MalfunctionJun 11, 2024Failure to Sense; Calibration Problem; Failure to Sense; Calibration Problem
IT WAS REPORTED THAT THE CO2 SENSOR FAILED DURING HIGH CALIBRATION. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19510962 ↗MalfunctionMay 14, 2024Crack; Incorrect, Inadequate or Imprecise Result or Readings; Crack; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE DEVICE SCREEN WAS CRACKED AND READINGS WERE INACCURATE. IT IS UNKNOWN IF THERE WAS PHYSICAL DAMAGE. PATIENT INVOLVEMENT IS UNKNOWN. NO HARM HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19313589 ↗MalfunctionJan 19, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE DEVICE POWERS ON BUT DISPLAYS A BUNCH OF LINES, AND NO DATA IS COMING ACROSS, IT WAS JUST A BLANK SCREEN. TRIED PUTTING A NEW SCREEN ON AND STILL HAVING THE SAME ISSUE. PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18545978 ↗MalfunctionAug 7, 2023Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate
IT WAS REPORTED THAT THE DEVICE'S CARBON MONOXIDE (C02) READINGS ARE NOT ACCURATE AND THE UNIT WILL NOT CALIBRATE. PATIENT INVOLVEMENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17471189 ↗MalfunctionMar 21, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE DEVICE IS NOT GIVING THE CORRECT VALUE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16588590 ↗MalfunctionSep 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE DEVICE READING WAS INACCURATE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15422606 ↗MalfunctionSep 13, 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 15409663 ↗MalfunctionSep 13, 2022Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE ETCO2 READING IS NOT ACCURATE. IN ADDITION, THE OCCLUSION MESSAGE AND ALARM DID NOT STOP AFTER REMOVAL OF PATIENT ATTACHMENT AND MOISTURE FILTER. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15409642 ↗MalfunctionSep 13, 2022Output Problem; Output Problem
IT WAS REPORTED THAT THE DEVICE WAS PRESENTING INACCURATE RESULTS. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15409640 ↗MalfunctionSep 13, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE READING WAS INACCURATE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15409633 ↗MalfunctionSep 10, 2022Device Alarm System; Failure to Power Up; Defective Device; Device Alarm System; Failure to Power Up; Defective Device
IT WAS REPORTED THAT THERE WAS A RATTLING INSIDE THE DEVICE. IT WAS ALSO REPORTED THE DEVICE EXHIBITED MEMORY CHECK ERROR WITH A SMALL BLACK SPOT ON THE SCREEN, ALARM BELL, AND THE YELLOW AND RED LIGHTS WOULD FLASH. IT WAS REPORTED THAT THE ONLY WAY TO STOP THIS ALARM WAS TO REMOVE THE BATTERY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397570 ↗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 15338588 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD AN EPROM C SUM ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15330207 ↗MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE DEVICE WAS NOT READING CARBON DIOXIDE CORRECTLY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15328844 ↗MalfunctionAug 31, 2022Gas Output Problem; Gas Output Problem
IT WAS REPORTED THAT THE GAS WAS NOT WORKING AS THE UNIT WAS SAYING THE GAS WAS NOT UP TO A CERTAIN AMOUNT; HOWEVER, THE GAS WAS AT THE AMOUNT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15328384 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE SUSPECT DEVICE INDICATED CO2 SENSOR ERROR MESSAGE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15328049 ↗MalfunctionAug 31, 2022Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow
IT WAS REPORTED THAT THE DEVICE WAS GIVING AN OCCLUSION ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326505 ↗MalfunctionAug 30, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD A CO2 SENSOR ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15322807 ↗MalfunctionAug 30, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD AN EPROM C SUM ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15322264 ↗MalfunctionAug 30, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THE DEVICE HAD MEMORY CHECK ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15320416 ↗MalfunctionAug 30, 2022Incorrect Measurement; Calibration Problem; Incorrect Measurement; Calibration Problem
IT WAS REPORTED THAT THE DEVICE HAD A LOW CARBON DIOXIDE (CO2) ERROR AND THE DEVICE WAS UNSTABLE DURING CALIBRATION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15320163 ↗MalfunctionAug 30, 2022Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT THE DEVICE SHOWED "EEPROM CSUM" ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15319480 ↗MalfunctionAug 29, 2022Defective Component; Defective Component
IT WAS REPORTED THAT THE END TITLE PART DID NOT WORK. THERE WAS AN ERROR OF CO2 NOT STABLE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15312109 ↗
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.