BCI 3301A1Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 30843418000849), received between Aug 29, 2021 and Mar 21, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Low Readings; Low Readings

  IT WAS STATED THAT THE DOCTORS AND NURSES WERE GIVING A PATIENT LOW SPO2, "IN THE 80". WHEN THEY SEND THE PATIENT TO THE EMERGENCY ROOM, THEY GET A CALL FROM THE EMERGENCY ROOM STATING THE SPO2 WAS 93. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951073 ↗
• MalfunctionMar 21, 2024Low Readings; Low Readings

  IT WAS STATED THAT THE DOCTORS AND NURSES WERE GIVING A PATIENT LOW SPO2, "IN THE 80." WHEN THEY SEND THE PATIENT TO THE EMERGENCY ROOM, THEY GET A CALL FROM THE EMERGENCY ROOM STATING THE SPO2 WAS 93. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951059 ↗
• MalfunctionMar 21, 2024Low Readings; Low Readings

  IT WAS STATED THAT THE DOCTORS AND NURSES WERE GIVING A PATIENT LOW SPO2, "IN THE 80". WHEN THEY SEND THE PATIENT TO THE EMERGENCY ROOM, THEY GET A CALL FROM THE EMERGENCY ROOM STATING THE SPO2 WAS 93. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951030 ↗
• MalfunctionMar 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DOCTORS AND NURSES ARE GIVING PATIENTS LOW SPO2 IN THE 80 AND WHEN THEY SEND THE PATIENT TO THE EMERGENCY ROOM, THEY GET A CALL FROM THE EMERGENCY ROOM STATING THE SPO2 WAS 93. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18945730 ↗
• MalfunctionMar 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE WAS GIVING PATIENTS LOW SPO2 IN THE 80 AND WHEN THE DOCTORS AND NURSES SEND THE PATIENT TO THE EMERGENCY ROOM, THEY GET A CALL FROM THE EMERGENCY ROOM STATING THE SPO2 WAS 93. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18945707 ↗
• MalfunctionMar 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE WAS GIVING PATIENTS LOW SPO2 IN THE 80 AND WHEN THE DOCTORS AND NURSES SEND THE PATIENT TO THE EMERGENCY ROOM, THEY GET A CALL FROM THE EMERGENCY ROOM STATING THE SPO2 WAS 93. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18945464 ↗
• MalfunctionOct 10, 2023Data Problem; Data Problem

  ADDITIONAL INFORMATION RECEIVED: THERE IS 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 17905291 ↗
• MalfunctionNov 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE WAS NOT READING ACCURATELY AND SOMETIMES NOT READING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708052 ↗
• MalfunctionSep 17, 2022Overheating of Device; Data Problem; Overheating of Device; Data Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15443258 ↗
• MalfunctionAug 31, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE IS PRESENTING WITH AN ERROR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327077 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE WAS NOT READING ACCURATELY AND SOMETIMES NOT READING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326950 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE WAS NOT READING ACCURATELY AND SOMETIMES NOT READING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326935 ↗
• MalfunctionAug 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DEVICE IS SHOWING DIFFERENT READINGS IN CLOSE PROXIMITY OF TIME, THEREFORE READINGS ARE NOT DEPENDABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320420 ↗
• MalfunctionOct 31, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT A SMITHS MEDICAL OXIMETER WON'T TURN ON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 12725733 ↗
• MalfunctionOct 31, 2021Failure to Power Up

  IT WAS REPORTED THAT A SMITHS MEDICAL OXIMETER IS NOT TURNING ON. NO PATIENT INVOLVEMENT

  Patient problems: Insufficient Information

  MAUDE report 12725633 ↗
• MalfunctionAug 29, 2021Circuit Failure; Circuit Failure

  INFORMATION RECEIVED A SMITHS MEDICAL PATIENT MONITORING/BCI OXIMETER HANDHELD - 3301 NEEDS A MAIN NEW BOARD, ACCORDING TO TECHNICIAN. UNKNOWN IF PATIENT INVOLVEMENT OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 12381387 ↗