BCI WW3078Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30843418001099), received between Feb 25, 2022 and Oct 10, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2023Failure to Sense; Failure to Sense

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT OR CLINICAL INJURY. THE OUTCOME WAS RESOLVED.

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

  MAUDE report 17905410 ↗
• MalfunctionSep 14, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING A HOSPITAL PRE-USE CHECK, THE CUSTOMER NOTICED THAT THE OXYGEN SATURATION (SPO2) VALUE WAS UNABLE TO BE MEASURED CORRECTLY BY THE EAR PROBE. IT WAS SUSPECTED THAT A WIRE BREAK OCCURRED IN THE PRODUCT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422882 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT FLUCTUATIONS WERE NOTED WHILE USING THE EAR SENSOR. ANOTHER SENSOR WAS USED AND IT WORKED FINE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326883 ↗
• MalfunctionAug 30, 2022Intermittent Capture; Intermittent Capture

  IT WAS REPORTED THAT THE OXIMETER IS NOT READING CORRECTLY, THE CORD HAD TO BE MANEUVERED TO GET THE RED LIGHT TO TURN ON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320808 ↗
• MalfunctionAug 30, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE UNIT LIGHTS UP AND APPEARS TO WORK, BUT THERE IS NO READING FROM THE EAR SENSOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320741 ↗
• MalfunctionAug 30, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT THE EAR PROBE WAS NOT READING THE SIGNAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320700 ↗
• MalfunctionAug 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DEVICES ARE READING HIGHER THAN THE FINGER PROBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320386 ↗
• MalfunctionFeb 25, 2022Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE OXIMETER PRODUCES ONLY INTERMITTENT AND INACCURATE BPM READINGS AND WILL NOT MEASURE O2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13603557 ↗