BD Alaris™ ETCO2 Module, Model 8300 (REF 8300BDADXEN123)Recalls & reported problems
Carefusion 303, Inc. · BD Alaris™ ETCO2 Module, Model 8300 v12.3 · Class 2
Quick summary
This BD Alaris ETCO2 module measures exhaled carbon dioxide for patient monitoring. Its 489 reports most often describe communication failures, cracks and calibration problems. Recent reports describe error codes, a broken faceplate and failed preventive maintenance. The reports include no injuries and no deaths. No recalls name this device. Reports fell from 318 the year before to 140 in the latest year.
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
- 485
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 485 adverse event reports that list this exact device (DI 10885403516054), received between Jun 20, 2024 and Aug 3, 2026 — classified as 485 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (283 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Communication or Transmission Problem283
- Crack157
- Failure to Calibrate77
- Corroded71
- Device Alarm System65
- Break46
- Calibration Problem44
- No Device Output36
Patient problems
- No Clinical Signs, Symptoms or Conditions484
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 485 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2026Failure to Calibrate
It was reported that the device had top front of face plate is broken. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113595 ↗MalfunctionJun 25, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE DEVICE HAD FPMT - FAILED PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25618613 ↗MalfunctionJun 1, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE DEVICE HAD 571.6241. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25346077 ↗MalfunctionApr 28, 2026Inadequate or Insufficient Training
IT WAS REPORTED 8300 ERROR 570.6200. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25015113 ↗MalfunctionApr 28, 2026Inadequate or Insufficient Training
IT WAS REPORTED ERROR CODE ON A MODEL 8300. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25014508 ↗MalfunctionApr 9, 2026Device Alarm System; Calibration Problem
IT WAS REPORTED THAT THE DEVICE HAD CO2 ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829060 ↗MalfunctionApr 8, 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 24815846 ↗MalfunctionApr 7, 2026Inadequate or Insufficient Training
IT WAS REPORTED 8300 ERROR 571.6241. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24797038 ↗MalfunctionApr 6, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE DEVICE HAD 571.6241. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24789707 ↗MalfunctionApr 6, 2026Inadequate or Insufficient Training
IT WAS REPORTED THAT THE ETCO2 FAILED LEAK DOWN TEST DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24789260 ↗MalfunctionApr 6, 2026Communication or Transmission Problem
IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24788553 ↗MalfunctionApr 3, 2026Inadequate or Insufficient Training
IT WAS REPORTED 8300 FAILED CO2 TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24772847 ↗MalfunctionMar 30, 2026Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD 570.65. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24727283 ↗MalfunctionMar 30, 2026Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD 570.65. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24726788 ↗MalfunctionMar 26, 2026Calibration Problem
IT WAS REPORTED THAT THE DEVICE HAD ROTARY DOOR DOES NOT CLOSE FREELY AND INLET COVER STUCK. DAMAGED FRONT CASE. FAILED ORIDION BOARD CO2 CAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698687 ↗MalfunctionMar 25, 2026Device Alarm System
IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 571.6241. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24686403 ↗MalfunctionMar 25, 2026Break
IT WAS REPORTED THAT THE DEVICE HAD ROTARY DOOR DOES NOT OPEN FREELY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24685482 ↗MalfunctionMar 24, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE 8300 HAD ERROR 571.6241 & 570.6500. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24679384 ↗MalfunctionMar 20, 2026No Device Output
IT WAS REPORTED THAT THE DEVICE HAD FAILED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647494 ↗MalfunctionMar 20, 2026Failure to Calibrate
IT WAS REPORTED THAT THE DEVICE HAD DISPOSABLE IS STUCK IN THE INLET. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647104 ↗MalfunctionMar 20, 2026No Device Output
IT WAS REPORTED THAT THE DEVICE HAD FAILED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646522 ↗MalfunctionMar 20, 2026No Device Output
IT WAS REPORTED THAT THE DEVICE HAD FAILED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646520 ↗MalfunctionMar 20, 2026No Device Output
IT WAS REPORTED THAT THE DEVICE HAD FAILED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646519 ↗MalfunctionMar 20, 2026No Device Output
IT WAS REPORTED THAT THE DEVICE HAD FAILED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646514 ↗MalfunctionMar 19, 2026Communication 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 24641103 ↗
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-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
- Trilogy Evo EU2100X19Respironics, Inc. · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.