BCI 9004000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10610586036811), received between Sep 8, 2021 and Sep 14, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Calibrate” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2022Inappropriate Waveform; Intermittent Loss of Power; Inappropriate Waveform; Intermittent Loss of Power

  IT WAS REPORTED THAT THE DEVICE WAS NOT GIVING THE PROPER WAVE FORM, THE PUMP STARTS AND STOPS, AND THE AC ADAPTOR WAS WORN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422665 ↗
• MalfunctionSep 14, 2022Inappropriate Waveform; Naturally Worn; Power Problem; Inappropriate Waveform; Naturally Worn; Power Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOT GIVING THE PROPER WAVEFORM, PUMP STARTS/STOPS, AND THE AC ADAPTOR IS WORN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422562 ↗
• MalfunctionSep 6, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE WEAK REFLECTIONS AND SOMETIMES FLAT LINES OCCURRING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15365930 ↗
• MalfunctionSep 1, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE DEVICE REJECTED THE POWER CORD WHEN PLUGGED INTO THE UNIT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334399 ↗
• MalfunctionSep 1, 2022Device Alarm System; No Display/Image; Device Alarm System; No Display/Image

  IT WAS REPORTED THAT OCCLUSION MESSAGE OCCURRED THEN THE DISPLAY STOPPED WORKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334249 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE WEAK REFLECTIONS AND SOMETIMES FLAT LINES OCCURRING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328499 ↗
• MalfunctionFeb 8, 2022Sparking; Sparking

  IT WAS REPORTED THAT A SPARK WAS EMITTED BY THIS UNIT WHILE BEING USED BY A PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13483923 ↗
• MalfunctionNov 3, 2021Failure to Cycle; Failure to Calibrate; Failure to Cycle; Failure to Calibrate

  (B)(4) - THE HIGH CALIBRATION IS UNSTABLE AND CALIBRATION IS STARTING TO TAKE LONGER. THE SECOND PROBLEM STATED BY STAFF IS THAT IT DOES NOT CALCULATE ETCO2 INTERMITTENTLY, WHERE THEY CAN SEE THE BREATHS BUT THERE IS NO ETCO2 CALCULATION.

  Patient problems: Insufficient Information

  MAUDE report 12749040 ↗
• MalfunctionOct 26, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT OCCLUSION WAS SUSPECTED. THE ISSUE WAS DISCOVERED DURING INSPECTION WITH NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698173 ↗
• MalfunctionSep 8, 2021Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THE DEVICE WAS FAILING CALIBRATION.

  Patient problems: Insufficient Information

  MAUDE report 12442508 ↗

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