BCI 1303Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517042511), received between Nov 30, 2017 and Aug 9, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INFORMATION RECEIVED A SMITHS MEDICAL PATIENT MONITORING/BCI OXIMETER DISPOSABLES REPORTED SENSORS SHOW DEFECTS AFTER 1 TO 2 DAYS IN USE. CUSTOMER STATED THEY DO NOT DISSIPATE, PROVIDE INCORRECT MEASURE VALUES AND THE CABLES OF NEW SENSORS ARE ALREADY EXPOSED AS MISSING CABLE COVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294088 ↗
• MalfunctionAug 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INFORMATION RECEIVED A SMITHS MEDICSL PATIENT MONITORING/BCI OXIMETER DISPOSABLES REPORTED SENSORS SHOW DEFECTS AFTER 1 TO 2 DAYS IN USE. CUSTOMER STATED THEY DO NOT DISSIPATE, PROVIDE INCORRECT MEASURE VALUES AND THE CABLES OF NEW SENSORS ARE ALREADY EXPOSED AS MISSING CABLE COVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294086 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT SUSTAINED A BURN (REDNESS) WHILE USING A BCI® DISPOSABLE SENSOR. THE PATIENT WAS TAKEN TO THE HOSPITAL (COULD HAVE BEEN FOR SOMETHING ELSE). THE DOCTOR INFORMED THE MOM THAT THE BURN COULD HAVE BEEN DUE TO THE PROBE. THE PATIENT WAS TREATED WITH VENELEX OINTMENT FOR A DEEP TISSUE WOUND ON LEFT BIG TOE, BURN MARK ON RIGHT FOOT, AND BURN ON SIDE OF FOOT. VENELEX OINTMENT IS USED TO PROMOTE WOUND HEALING. NO OTHER ADVERSE EVENTS REPORTED.

  Patient problems: Burn(s)

  MAUDE report 7072414 ↗