INVOS SNNRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521106083), received between Jul 16, 2024 and Jul 16, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2024Erratic or Intermittent Display; Low Readings; Erratic or Intermittent Display; Low Readings

  ACCORDING TO THE REPORTER, THE SENSOR CONTINUED TO HAVE INTERMITTENT READINGS WHEN THE PATIENT WAS IN THE PRONE POSITION. THERE WAS A PERIOD OF TIME WHEN IT READ THAT IT WAS VERY LOW, 15 TO 28, THEN IN 70S. THE BLOOD GAS RESULT OBTAINED WAS FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751701 ↗
• MalfunctionJul 16, 2024Erratic or Intermittent Display; Low Readings; Erratic or Intermittent Display; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, WHEN THE PATIENT WAS PLACED IN A PRONE POSITION, THE FLANK SENSOR HAD NO DIFFICULTIES WITH THE READINGS. BUT WHEN THE PATIENT WAS PLACED IN A SUPINE POSITION, IT WOULD GO BACK TO GIVING INTERMITTENT READINGS. IT WAS ALSO STATED THAT THE READINGS WERE LOWER THAN EXPECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751678 ↗