BCI 3043Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 15019517042542), received between Dec 19, 2023 and Dec 22, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (12 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Failure to Sense; Failure to Sense

  IT WAS REPORTED THE OXIMETRY PROBE'S SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE AND THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384220 ↗
• MalfunctionDec 21, 2023Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE OXIMETER FAILED DURING A READ, THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE AND THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376472 ↗
• MalfunctionDec 19, 2023Unable 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 THERE WAS A FAILURE DURING THE READ. THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE WHEN THE FAILURE WAS DETECTED, HOWEVER THERE WAS NO ONE HARMED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360146 ↗
• MalfunctionDec 19, 2023Unable 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 THERE WAS A FAILURE DURING THE READ. THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE WHEN THE FAILURE WAS DETECTED, HOWEVER THERE WAS NO ONE HARMED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360114 ↗
• MalfunctionDec 19, 2023Unable 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 THERE WAS A FAILURE DURING THE READ. THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE WHEN THE FAILURE WAS DETECTED, HOWEVER THERE WAS NO ONE HARMED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360098 ↗
• MalfunctionDec 19, 2023Unable 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 THERE WAS A FAILURE DURING THE READ. THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE WHEN THE FAILURE WAS DETECTED, HOWEVER THERE WAS NO ONE HARMED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360094 ↗
• MalfunctionDec 19, 2023Unable 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 THERE WAS A FAILURE DURING THE READ. THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE WHEN THE FAILURE WAS DETECTED, HOWEVER THERE WAS NO ONE HARMED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360078 ↗
• MalfunctionDec 19, 2023Unable 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 THERE WAS A FAILURE DURING THE READ. THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE WHEN THE FAILURE WAS DETECTED, HOWEVER THERE WAS NO ONE HARMED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360047 ↗
• MalfunctionDec 19, 2023Unable 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 THERE WAS A FAILURE DURING THE READ. THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE WHEN THE FAILURE WAS DETECTED, HOWEVER THERE WAS NO ONE HARMED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360020 ↗
• MalfunctionDec 19, 2023Unable 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 THERE WAS A FAILURE DURING THE READ. THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE WHEN THE FAILURE WAS DETECTED, HOWEVER THERE WAS NO ONE HARMED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360001 ↗
• MalfunctionDec 19, 2023Unable 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 THERE WAS A FAILURE DURING THE READ. THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE WHEN THE FAILURE WAS DETECTED, HOWEVER THERE WAS NO ONE HARMED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359978 ↗
• MalfunctionDec 19, 2023Unable 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 THERE WAS A FAILURE DURING THE READ. THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE WHEN THE FAILURE WAS DETECTED, HOWEVER THERE WAS NO ONE HARMED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359975 ↗
• MalfunctionDec 19, 2023Unable 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 THERE WAS A FAILURE DURING THE READ. THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE WHEN THE FAILURE WAS DETECTED, HOWEVER THERE WAS NO ONE HARMED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359960 ↗
• MalfunctionDec 19, 2023Unable 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 THERE WAS A FAILURE DURING THE READ. THERE WAS AN INCORRECT READ OF THE SPO2. THE TYPE Y NEONATAL OXIMETRY SENSORS STOPPED WORKING WITHIN A SHORT PERIOD OF TIME. THE SPO2 VALUES WERE INCONSISTENT WITH THE PATIENT'S CONDITION. THE EVENT OCCURRED DURING PATIENT USE WHEN THE FAILURE WAS DETECTED, HOWEVER THERE WAS NO ONE HARMED AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357014 ↗