BD Alaris™ ETCO2 Module, Model 8300 (REF 8300BDADXEN126)Recalls & reported problems
Carefusion 303, Inc. · BD Alaris™ ETCO2 Module, Model 8300 v12.6 · Class 2
All models of BD Alaris ETCO2 Module, Model 8300 (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD Alaris ETCO2 module is a gas analyzer that measures carbon dioxide in exhaled breath. Its 464 reports mostly describe calibration problems, communication failures, alarm faults and devices giving no output. There are no deaths and no injuries, and reports rose sharply to 419 in the last 12 months from 45 in the 12 months before. 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
- 471
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 471 adverse event reports that list this exact device (DI 10885403520761), received between Sep 26, 2025 and Sep 30, 2026 — classified as 471 malfunctions.
The most frequently reported specific device problem is “Calibration Problem” (190 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Calibration Problem190
- Communication or Transmission Problem142
- Device Alarm System90
- Failure to Calibrate50
- No Device Output27
- Break23
- Inadequate or Insufficient Training21
- Loose or Intermittent Connection21
Patient problems
- No Clinical Signs, Symptoms or Conditions469
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 471 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Calibrate
It was reported that the device had will not calibrate. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942112 ↗MalfunctionSep 29, 2026Failure to Calibrate
It was reported that the device had failed accuracy test and unable to calibrate. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932676 ↗MalfunctionSep 29, 2026Communication or Transmission Problem
It was reported that the device does not have tubing loaded error message when tubing is loaded. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931442 ↗MalfunctionSep 29, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929892 ↗MalfunctionSep 29, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929890 ↗MalfunctionSep 29, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929868 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported by customer their ETCO2 Module is failing. There was an Oridion Board- Failed- Bit Test error (error code 570.6200) and Oridion Board- Comm Failure error (error code 570.6500) on different dates. There was no patient involvement, as these codes were noted when the device was pulled from the floor and logs downloaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896554 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported by customer their ETCO2 Module is failing. There was an Oridion Board- Failed- Bit Test error (error code 570.6200) and Oridion Board- Comm Failure error (error code 570.6500) on different dates. There was no patient involvement, as these codes were noted when the device was pulled from the floor and logs downloaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896552 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported by customer their ETCO2 Module is failing. There was an Oridion Board- Failed- Bit Test error (error code 570.6200) and Oridion Board- Comm Failure error (error code 570.6500) on different dates. There was no patient involvement, as these codes were noted when the device was pulled from the floor and logs downloaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896551 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported by customer their ETCO2 Module is failing. There was an Oridion Board- Failed- Bit Test error (error code 570.6200) and Oridion Board- Comm Failure error (error code 570.6500). There was no patient involvement, as these codes were noted when the device was pulled from the floor and logs downloaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895435 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
It was reported that the device had errors 570.6200, 571.6210, 570.6500 in log. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895429 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported by customer their ETCO2 Module is failing. There was an Oridion Board- Failed- Bit Test error (error code 570.6200) and Oridion Board- Comm Failure error (error code 570.6500). There was no patient involvement, as these codes were noted when the device was pulled from the floor and logs downloaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895426 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
It was reported that the device had disposable not connected error. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895127 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported that the device had error code 570.6200. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895101 ↗MalfunctionSep 25, 2026Device Alarm System
It was reported by customer their ETCO2 Module is failing. There was an Oridion Board- Failed- Bit Test error (error code 570.6200) and Oridion Board- Comm Failure error (error code 570.6500). There was no patient involvement, as these codes were noted when the device was pulled from the floor and logs downloaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893195 ↗MalfunctionSep 24, 2026Calibration Problem
It was reported that the customer checked the new modules today and found that one of the modules failed the CO2 accuracy test. It did not recognize that gas was flowing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881884 ↗MalfunctionSep 24, 2026Pumping Stopped
It was reported that the device had turns itself on and off. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881184 ↗MalfunctionSep 24, 2026Communication or Transmission Problem
It was reported that the device had error code 570. 6200. Board Safety System. BIT Failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880559 ↗MalfunctionSep 24, 2026Device Alarm System; Communication or Transmission Problem
It was reported that the device had error code 570.6500. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880525 ↗MalfunctionSep 23, 2026Device Alarm System; Communication or Transmission Problem
It was reported that the device kept saying it was disconnected. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868097 ↗MalfunctionSep 15, 2026Failure to Calibrate; Calibration Problem
It was reported that the device had failed CO2 sensor calibration. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770841 ↗MalfunctionSep 10, 2026Calibration Problem
It was reported that the device had failed CO2 sensor calibration. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714873 ↗MalfunctionSep 10, 2026Calibration Problem
It was reported that the device had Leak down test failed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714865 ↗MalfunctionSep 9, 2026Calibration Problem
It was reported that the device had Failed leak down test. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50688765 ↗MalfunctionSep 3, 2026Device Alarm System; Communication or Transmission Problem; Failure of Device to Self-Test
It was reported that the device had error code 570.6200. Upon testing, the biomed also discovered a "6500 error" in the logs. There was patient involvement, but no harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50579664 ↗
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
- 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
- Trilogy Evo EU2100X19Respironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls0 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page