BCI 9004051Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10610586036873), received between Feb 9, 2017 and May 25, 2023 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K970209); 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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2023Power Problem; Unexpected Shutdown; Power Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE WONT STAY ON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004216 ↗
• MalfunctionSep 29, 2022Device Alarm System; Defective Component; Device Alarm System; Defective Component

  ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 02-OCT-2022. EVENT DATE WAS UPDATED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505129 ↗
• MalfunctionSep 22, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE POWER LIGHTS WERE FLASHING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15467077 ↗
• MalfunctionSep 14, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE DEVICE HAD ERRATIC READINGS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422572 ↗
• MalfunctionSep 2, 2022Device Alarm System; Battery Problem; Device Alarm System; Battery Problem

  IT WAS REPORTED THAT THE DEVICE WAS SHOWING CONSTANT OCCLUSION ERROR AND BATTERY DIES FAST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349735 ↗
• MalfunctionSep 1, 2022Device Alarm System; Mechanical Problem; Device Alarm System; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS AN OCCLUSION ISSUE, PARTS HAD BEEN REPLACED BUT STILL HAVING THIS ISSUE MONTHS LATER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334282 ↗
• MalfunctionSep 1, 2022Device Alarm System; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Read Input Signal; Device Alarm System; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Read Input Signal

  IT WAS REPORTED THAT THE DEVICE COULD NOT COLLECT DATA AND THE OCCLUSION MESSAGE COMES UP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334164 ↗
• MalfunctionAug 31, 2022Break; Unable to Obtain Readings; Break; Unable to Obtain Readings

  IT WAS REPORTED THAT THE DEVICE WAS NOT READING CORRECTLY AND CABLE WAS CUT OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328812 ↗
• MalfunctionAug 31, 2022Data Problem; Data Problem

  IT WAS REPORTED THAT THERE WAS AN INACCURATE DATA ISSUE WITH THE REPORTED DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326710 ↗
• MalfunctionAug 31, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT THE DEVICE WAS READING INCORRECTLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326498 ↗
• MalfunctionApr 5, 2022Defective Alarm; Unintended System Motion; Defective Alarm; Unintended System Motion

  IT WAS REPORTED THAT THE FAN CONSTANTLY RUNS AND ALARMS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015617 ↗
• MalfunctionMar 30, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THE DEVICE WOLD CALIBRATE CORRECTLY WITH 10% CO2, READING IN THE TWENTIES WHEN HOOKED UP TO A PATIENT. CONFIRMED THE EVENT WAS NOT DUE TO THE PATIENT, BY USING A SECONDARY (WORKING) DEVICE. NOT ABLE TO DO A FACTORY CALIBRATION, WOULD LIKE TO SEND IT IN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13950161 ↗
• MalfunctionFeb 24, 2022Unable to Obtain Readings; Calibration Problem; Unable to Obtain Readings; Calibration Problem

  IT WAS REPORTED THAT THERE IS AN UNSTABLE CO2 READING AND CALIBRATION. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595016 ↗
• MalfunctionNov 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE COMPORT AND SIGNALS ARE INCORRECT ON A SMITHS MEDICAL CAPNOGRAPH. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808294 ↗
• MalfunctionNov 7, 2021Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT NO WAVE AND NOT RESPONDING TO BREATHS, GIVING INTERMITTENT ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12763904 ↗
• MalfunctionNov 6, 2021Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT A SMITHS MEDICAL CAPNOGRAPH HAS NO WAVE AND NOT RESPONDING TO BREATHS (LOUD WHEN TUNED ON). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755557 ↗
• MalfunctionOct 30, 2021Device Alarm System; Device Alarm System

  WHILE CALIBRATING IT GAVE AN OCCLUSION ERROR.

  Patient problems: Insufficient Information

  MAUDE report 12725431 ↗
• MalfunctionOct 15, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE CASING WAS BROKEN AND THE SCREWS WEREN'T FITTING. NO ADVERSE AFFECTS.

  Patient problems: Insufficient Information

  MAUDE report 12643475 ↗
• MalfunctionOct 15, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT THE DEVICE STARTING HAVING A BLANK SCREEN. NO ADVERSE AFFECTS TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643382 ↗
• MalfunctionAug 18, 2021Power Problem; Power Problem

  INFORMATION RECEIVED A SMITHS MEDICAL PATIENT MONITORING/BCI CAPNOGRAPHY MONITOR CAPNOCHECK SLEEP - 9004 IS MAKING NOISE AND SHUTTING OFF ON ITS OWN. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 12337788 ↗
• MalfunctionApr 26, 2019Calibration Problem; Calibration Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BCI CAPNOCHECK SLEEP OXIMETER "WILL NOT HOLD 1VOLT CALIBRATION". NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8557474 ↗
• MalfunctionJan 10, 2019Low Readings; Calibration Problem; Low Readings; Calibration Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BCI CAPNOCHECK SLEEP OXIMETER DISPLAYED LOW CO2 READINGS AFTER CALIBRATION. THE REPORTER NOTED TWO DIFFERENT GAS SOURCES WERE USED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8237128 ↗
• MalfunctionFeb 24, 2018Overheating of Device; Electronic Property Issue; Overheating of Device; Electronic Property Issue

  IT WAS REPORTED THAT WHEN PLUGGING INTO THE BACK OF A BCI® CAPNOCHECK® SLEEP CAPNOGRAPH/OXIMETER, ELECTRICAL CURRENTS WERE SEEN COMING OUT OF IT. REPORTER STATED THE MACHINE WOULD NOT TURN ON AND IT WAS HOT WHILE RUNNING. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7294507 ↗
• MalfunctionFeb 9, 2017Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT A BCI® CAPNOCHECK® SLEEP CAPNOGRAPH/OXIMETER WAS HOT AND SMOKING. THE DEVICE'S GREEN POWER LIGHT DID NOT FUNCTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6315691 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970209. One submission often covers many models, so check the product and lot details in each record.

• Z-1014-2013 · Feb 6, 2013 · Terminated
  Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Pr