INVOS SAFB-SM/INTL20Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20884521105901), received between May 8, 2019 and Jun 2, 2025 — classified as 1 death, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT THE UNIT EXHIBITED LOW RSO2 READINGS, WITH A BASELINE OF 58 OR A 20% DECREASE FROM THE EXPECTED BASELINE. TWO SIMILAR INCIDENTS HAD PREVIOUSLY OCCURRED IN THE SAME BLOCK. DURING CEREBRAL PERFUSION MONITORING UNDER ALR AND SEDATION, APPROXIMATELY 30 MINUTES AFTER CLAMPING THE CAROTID ARTERY, THE SENSOR ON THE RIGHT SIDE DISPLAYED AN UNEXPLAINED DROP IN VALUES, SUGGESTING CEREBRAL HYPOPERFUSION. HOWEVER, NO CLINICAL CHANGES WAS OBSERVED. THE ISSUE WAS RESOLVED BY REPLACING THE SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127500 ↗
• MalfunctionMay 22, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT THE UNIT EXHIBITED LOW RSO2 READINGS, WITH A BASELINE OF 58 OR A 20% DECREASE FROM THE EXPECTED BASELINE. DURING CEREBRAL PERFUSION MONITORING UNDER ALR AND SEDATION, APPROXIMATELY 30 MINUTES AFTER CLAMPING THE CAROTID ARTERY, THE SENSOR ON THE RIGHT SIDE DISPLAYED AN UNEXPLAINED DROP IN VALUES, SUGGESTING CEREBRAL HYPOPERFUSION. HOWEVER, NO CLINICAL CHANGES WAS OBSERVED. THE ISSUE WAS RESOLVED BY REPLACING THE SENSOR. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070129 ↗
• MalfunctionMar 17, 2025Failure to Analyze Signal; Low Readings; Failure to Analyze Signal; Low Readings

  IT WAS REPORTED THAT DURING USE, THE SENSOR HAD LOW READINGS ON CHANNEL 1 THEN DROPPED OUT AND NO LONGER PICKED UP. CHANNEL 1 SHOWED A READING OF 59 WHILE CHANNEL 2 SHOWED 83. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617921 ↗
• MalfunctionJun 28, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S SENSOR HAD CAUSED SKIN REACTION TO THE PATIENT. IT WAS RECOMMENDED TO CHANGE THE SENSOR AFTER 24 HOURS.

  Patient problems: Inflammation

  MAUDE report 14842064 ↗
• MalfunctionJun 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE SENSOR WAS USED ON A PEDIATRIC PATIENT WHO UNDERGONE HEART SURGERY. DURING PROCEDURE, THE SENSOR WAS PLACED ON THE PATIENT. AFTER PROCEDURE, IT WAS ALSO USED FOR LONGER THAN 24HRS ON THE SAME SPOT. THE DEVICE HAD CAUSED SKIN REACTION TO THE PATIENT.

  Patient problems: Inflammation

  MAUDE report 14830234 ↗
• DeathMay 28, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, A PATIENT CAME WITH AN AORTIC DISSECTION. THE BASELINE OF THE DEVICE WAS LEFT 72 AND RIGHT 57. THE SURGERY TOOK SEVERAL HOURS, THEY BROUGHT THE PATIENT TO THE ICU, BUT THE PATIENT DIED A FEW HOURS LATER. IT WAS ALSO INDICATED THAT BEFORE AND AFTER THE PROCEDURE, THE DEVICE DID WORK CORRECTLY. IT IS UNKNOWN AT THIS TIME IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Death

  MAUDE report 8647858 ↗
• MalfunctionMay 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED SIGNS OF BURN. IT WAS INDICATED THAT THIS RESULTED TO A RED TISSUE INJURY TO THE PATIENT.

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

  MAUDE report 8593491 ↗