INVOS SAFB-SM/INTLRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20884521104225), received between Jun 22, 2017 and Aug 12, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Low 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN INTENSIVE CARE UNIT (ICU) AND PART OF A RESEARCH STUDY, THERE WAS A SKIN INTEGRITY ON THE FOREHEAD AND THE SENSORS WERE PERMANENTLY REMOVED. PATIENT EXPERIENCED DEEP TISSUE INJURY ON THE LEFT FOREHEAD AND STAGE TWO ULCERS ON THE RIGHT FOREHEAD. THE STUDY PROBES WAS APPLIED, PATIENT CRITICALLY ILL ON MULTIPLE VASOPRESSORS THROUGHOUT HIS ADMISSION. STUDY PROBES REMOVED ONCE ULCERS NOTED. THE PATIENT WAS PRESENT ALIVE AND ON LIFE SUPPORT DUE TO THEIR PREEXISTING CONDITION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 22785139 ↗
• MalfunctionNov 6, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SENSOR DID NOT MEASURE PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625014 ↗
• MalfunctionAug 13, 2024Low Readings; Manufacturing, Packaging or Shipping Problem; Low Readings; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING USE, WHEN THE NEW SENSOR WAS OPENED AND APPLIED TO A PATIENT, THE READING WAS ABNORMALLY LOW ON ONLY ONE SIDE. THE EXACT NUMBER WAS UNKNOWN, BUT IT WAS SAID TO BE AROUND 30. WHEN ANOTHER SENSOR WAS OPENED AND APPLIED, IT RETURNED TO ITS PROPER VALUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971349 ↗
• MalfunctionOct 25, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE¿S MEASUREMENT VALUE STARTED TO DROPPED AT THE MIDDLE OF THE SURGERY AND REMAINED TO THE LOWEST VALUE. NO INCREASED IN VALUE WAS SEEN EVEN DURING PATIENT RECOVERY. SENSOR WAS REPLACED WITH A NEW ONE AND THE VALUE INCREASED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9238686 ↗
• MalfunctionAug 28, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE GAVE LOW RSO2 VALUE OF 15. THEY CHANGED THE CANNULA TO LARGER SIZE AND USED INOTROPES TO MANAGED BLOOD PRESSURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940304 ↗
• InjuryAug 13, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD REACTION OR PRESSURE INJURY TO PATIENT. THERE WAS GROSS SWELLING AND REDNESS WHERE ELECTRODES WERE PLACED, PATIENT HAD A FOLLOW UP AND AREA WAS STILL RED.

  Patient problems: Injury; Unspecified Tissue Injury

  MAUDE report 8890626 ↗
• InjuryJun 13, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE UNIT WAS USED ON BRAIN TUMOR SURGERY. THEREAFTER A RED SCAR WAS FOUND ON THE FOREHEAD OF THE PATIENT. THE RED SCAR WAS IN THE ALMOST SAME POSITION AS THE LIGHT RECEIVING PART AND THE LIGHT EMITTING PART. THE SURGERY TIME WAS ABOUT 12 HOURS. THE SENSOR WERE SET ON THE UPPER AND THE LOWER POSITION OF SENSOR. THE DOCTOR CONSIDERED IT WAS NOT A BURN SCAR BUT A PRESSURE SCAR.

  Patient problems: Injury; Unspecified Tissue Injury

  MAUDE report 8696078 ↗
• MalfunctionSep 18, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  CUSTOMER REPORTED THAT THE SITE OF SENSOR APPLICATION ON PATIENT HAD TURNED REDDISH BLACK IN COLOR 4 DAYS LATER. THERE IS PATIENT INVOLVEMENT BUT PATIENT HARM IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 6873506 ↗
• MalfunctionJun 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  CUSTOMER REPORTED THAT THE SITE OF SENSOR APPLICATION ON PATIENT HAD TURNED REDDISH BLACK IN COLOR FOUR DAYS POST-PROCEDURE. MEDTRONIC HAS REQUESTED ADDITIONAL INFORMATION ASSOCIATED WITH THE COMPLAINT AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT.

  Patient problems: No Information

  MAUDE report 6661763 ↗