BCI 8400DRecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ICU Medical BCI 8400D is a blood gas analyzer that measures carbon dioxide in blood samples. The 29 reports describe the unit alarming about occlusion, failing to calibrate or power up, showing error codes on the screen, and giving readings that were hard to read or unavailable. No deaths or injuries were reported. There are no recalls naming 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10610586036736), received between Dec 26, 2018 and Jan 14, 2025 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (9 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 System9
- Display or Visual Feedback Problem6
- Failure to Power Up4
- Display Difficult to Read2
- Failure to Calibrate2
- Unable to Obtain Readings2
- Application Program Problem1
- Calibration Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information7
- No Information3
- No Known Impact Or Consequence To Patient3
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2025Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED THAT DURING START-UP THE DEVICE WOULD NOT CALIBRATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21147836 ↗MalfunctionDec 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT "THE UNIT WAS OFF PER READING, RE-CALIBRATED". PATIENT INVOLVEMENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18352105 ↗MalfunctionSep 27, 2023Device Alarm System; Device Alarm System
ADDITIONAL INFORMATION RECEIVED. THIS WAS DISCOVERED DURING PREVENTATIVE MAINTENANCE. NO PATIENT INVOLVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17829764 ↗MalfunctionSep 1, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THERE WAS AN OCCLUDING MESSAGE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15337306 ↗MalfunctionSep 1, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT DEVICE IS OCCLUDING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15334070 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THERE WAS AN OCCLUSION ALARM WHEN POWERED ON. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327569 ↗MalfunctionAug 31, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THERE WAS A CONSTANT OCCLUSION ALARM. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327554 ↗MalfunctionAug 31, 2022Device Alarm System; Circuit Failure; Device Alarm System; Circuit Failure
IT WAS REPORTED THAT A C-SUM ERROR WAS DISPLAYED. DEVICE WOULD NOT BOOT UP AND KEPT FLASHING NEW CO2 SENSOR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326297 ↗MalfunctionAug 30, 2022Device Alarm System; Failure to Power Up; Device Alarm System; Failure to Power Up
IT WAS REPORTED THAT THE DEVICE WAS RECEIVED BACK FROM REPAIR WITH C-SUM ERROR DISPLAYED. THE DEVICE WOULD NOT POWER UP AND KEY BLINK WON'T POWER UP. IT KEPT FLASHING NEW CO2. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15322569 ↗MalfunctionAug 30, 2022Device Alarm System; Failure to Power Up; Device Alarm System; Failure to Power Up
IT WAS REPORTED THAT "C-SUM" ERROR WAS DISPLAYED. DEVICE WOULD NOT POWER UP. KEPT FLASHING NEW "CO2 SENSOR". NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15322260 ↗MalfunctionAug 30, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT UPON POWER UP AN ERROR APPEARED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15322155 ↗MalfunctionAug 30, 2022Application Program Problem; Application Program Problem
IT WAS REPORTED THAT THE DEVICE HAD EEPROM CSUM ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15320117 ↗MalfunctionAug 30, 2022Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THERE WAS CO2 SENSOR ERROR ON REPORTED DEVICE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15319997 ↗MalfunctionAug 30, 2022Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT THE DEVICE WAS SHOWING A CHECK SUM ERROR. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15319450 ↗MalfunctionAug 29, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE DEVICE WAS SHOWING AN ERROR MESSAGE "EE-PROM". NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15312052 ↗MalfunctionAug 4, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT HALF THE SCREEN WORKS ON THE DEVICE. NO PATIENT INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 15164126 ↗MalfunctionAug 4, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT HALF THE SCREEN WORKS ON THE DEVICE. NO PATIENT INJURY WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15164018 ↗MalfunctionNov 14, 2021Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT A SMITHS MEDICAL CAPNOGRAPH KEEPS REBOOTING AND SCREEN DAMAGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 12808345 ↗MalfunctionSep 30, 2021Display or Visual Feedback Problem; Calibration Problem; Display or Visual Feedback Problem; Calibration Problem
IT WAS REPORTED THAT THERE WAS A BROKEN LCD AND CALIBRATION ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12555884 ↗MalfunctionAug 20, 2021Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE DEVICE WAS NOT CAPTURING READINGS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12351116 ↗MalfunctionAug 20, 2021Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE DEVICE WAS NOT CAPTURING ANY READINGS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12351029 ↗MalfunctionNov 6, 2019Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BCI CAPNOCHECK II CAPNOGRAPH MONITOR HAD A BROKEN SCREEN. THE ISSUE WAS FOUND DURING THE DEVICE PLANNED MAINTENANCE. NO ADVERSE EFFECTS WERE REPORTED. .
Patient problems: No Patient Involvement
MAUDE report 9288465 ↗MalfunctionSep 11, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
INFORMATION WAS RECEIVED THAT THE SCREEN OF A SMITHS MEDICAL CAPNOCHECK MONITOR IS BLANK. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Information
MAUDE report 8996559 ↗MalfunctionSep 5, 2019Computer Software Problem; Computer Software Problem
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BCI CAPNOGRAPHY MONITOR CAPNOCHECK II HAD A CO2 ERROR MESSAGE AND SYSTEM FAILURE. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 8965930 ↗MalfunctionAug 23, 2019Failure to Power Up; Failure to Power Up
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL CAPNOGRAPHY MONITOR CAPNOCHECK DOES NOT POWER ON. IT WAS REPORTED DEVICE HAS ONLY BLACK LINES. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 8927546 ↗
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 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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