BCI 9004050Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10610586036866), received between Jul 20, 2018 and May 15, 2024 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024No Display/Image; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; No Display/Image; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE WAS NOT GIVING ACCURATE READINGS. SOMETIMES NO READINGS AT ALL. INTERMITTENTLY THE DISPLAY WILL GO BLANK AS WELL. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19326034 ↗
• MalfunctionSep 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE WAS NOT READING AIR PRESSURE CORRECTLY. EVENT OCCURRED PRIOR TO PATIENT USE. NO PATIENT HARM OR ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775621 ↗
• MalfunctionMay 3, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE MONITOR WOULD OCCLUDE ABOUT 45 MINUTES AFTER USING. NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 16864899 ↗
• MalfunctionSep 21, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE ERRORED CHECK SUM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461910 ↗
• MalfunctionSep 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409673 ↗
• MalfunctionSep 13, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE READINGS DROPPED TO ZERO AFTER 30-60 MINUTES OF OPERATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409664 ↗
• MalfunctionSep 13, 2022Erratic or Intermittent Display; Poor Quality Image; Incorrect, Inadequate or Imprecise Result or Readings; Erratic or Intermittent Display; Poor Quality Image; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE SCREEN WAS FLICKERING, DISPLAY WAS DIM, AND READINGS WERE OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409646 ↗
• MalfunctionSep 13, 2022Low Readings; Low Readings

  IT WAS REPORTED THAT THE DEVICE WAS READING VERY LOW. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409637 ↗
• MalfunctionSep 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE'S CARBON DIOXIDE READING ARE INACCURATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409630 ↗
• MalfunctionSep 13, 2022Low Readings; Noise, Audible; Low Readings; Noise, Audible

  IT WAS REPORTED THAT THE MOTOR POUND FORCE PER SQUARE INCH VALUE IS LOW, AND THE MOTOR IS LOUD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409629 ↗
• MalfunctionSep 12, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT CO2 READING WAS INACCURATELY HIGH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401787 ↗
• MalfunctionSep 12, 2022Pressure Problem; Pressure Problem

  IT WAS REPORTED THE CO2 READING REALLY HIGH OF 60. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401649 ↗
• MalfunctionSep 2, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PUMP STOPS WORKING AND C02 DROPS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348869 ↗
• MalfunctionSep 1, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE GAVE A CONSTANT OCCLUSION ALARM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15337482 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE CO2 READING IS NOT ACCURATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328950 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible; Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible

  IT WAS REPORTED THAT THE PRODUCT IS NOT READING CORRECTLY AND THE PUMP INSIDE IS MAKING MORE NOISE THAN USUAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328413 ↗
• MalfunctionAug 31, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE DEVICE TRENDS UPWARD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328376 ↗
• MalfunctionAug 31, 2022High Readings; High Readings

  IT WAS REPORTED THAT THERE WERE HIGH READINGS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328247 ↗
• MalfunctionAug 31, 2022Device Alarm System; Noise, Audible; Device Alarm System; Noise, Audible

  IT WAS REPORTED THERE WAS AN OCCLUSION ERROR AND THE PUMPS WERE LOUD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327553 ↗
• MalfunctionAug 31, 2022High Readings; High Readings

  IT WAS REPORTED THAT THERE WAS AN HIGH READINGS ISSUE WITH THE REPORTED DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326684 ↗
• MalfunctionAug 30, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE WORKED FOR AN HOUR AND THERE WAS A MAJOR ERROR MESSAGE POP-UP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322317 ↗
• MalfunctionAug 30, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE DEVICE FLOW RATE IS TO LOW PA. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320427 ↗
• MalfunctionAug 30, 2022Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE DEVICE HAD A CLOCK ERROR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320407 ↗
• MalfunctionAug 30, 2022Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT THE "CLOCK ERROR-RESET TIME/DATE" WAS OBSERVED AT REPORTED DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320074 ↗
• MalfunctionAug 30, 2022Failure to Run on Battery; Battery Problem; Failure to Run on Battery; Battery Problem

  IT WAS REPORTED THAT THE DEVICE DID NOT WORK AFTER INSERTING NEW BATTERY AND DISPLAYED AN ERROR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319773 ↗

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