INVOS CNN/SNN (UDI 10884521810372)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521810372), received between Jun 7, 2023 and Feb 6, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A WOUND WAS FORMED ON A CHILD'S FOREHEAD ASSOCIATED WITH THE USE OF THE SENSOR. IT WAS IN USED BETWEEN 12 TO 24 HOURS. THE PRODUCT WAS REPLACED AND WOUND WAS TREATED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21325535 ↗
• MalfunctionFeb 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A WOUND WAS FORMED ON A CHILD'S FOREHEAD ASSOCIATED WITH THE USE OF THE SENSOR. IT WAS IN USED BETWEEN 12 TO 24 HOURS. THE PRODUCT WAS REPLACED AND WOUND WAS TREATED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21324799 ↗
• MalfunctionJan 23, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT A WOUND WAS FORMED ON A CHILD'S FOREHEAD ASSOCIATED WITH THE USE OF THE SENSOR. IT WAS NOTED THAT THREE SENSORS FROM THE BOX WERE USED, ALL OF WHICH CAUSED SIMILAR WOUNDS. THE PRODUCT WAS REPLACED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21223523 ↗
• MalfunctionJan 23, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT A WOUND WAS FORMED ON A CHILD'S FOREHEAD ASSOCIATED WITH THE USE OF THE SENSOR. IT WAS NOTED THAT THREE SENSORS FROM THE BOX WERE USED, ALL OF WHICH CAUSED SIMILAR WOUNDS. THE PRODUCT WAS REPLACED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21223511 ↗
• MalfunctionJan 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A WOUND WAS FORMED ON A CHILD'S FOREHEAD ASSOCIATED WITH THE USE OF THE SENSOR. IT WAS IN USED BETWEEN 12 TO 24 HOURS. THE PRODUCT WAS REPLACED AND WOUND WAS TREATED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21223484 ↗
• MalfunctionNov 15, 2024Erratic or Intermittent Display; High Readings; Low Readings; Erratic or Intermittent Display; High Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD AN ERRATIC SPO2 (PERIPHERAL OXYGEN SATURATION) READING, RSO2 (REGIONAL OXYGEN SATURATION) VALUE WERE LOW 0 AND HIGH 60,70 AND 80. 2 CHANNELS WERE IN USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694936 ↗
• MalfunctionOct 31, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT HAD A BURN-LIKE LESION ON THE FOREHEAD DUE TO SENSOR.

  Patient problems: Localized Skin Lesion

  MAUDE report 20584455 ↗
• InjuryJul 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, SKIN BURN WAS FOUND IN THE AREAS WHERE THE SENSORS WERE USED, THE LEFT FRONTAL REGION AND THE RIGHT ILIAC. THE SENSOR REMAINED AT THE SITE OF THE SKIN INTEGRITY PROBLEM FOR 10 DAYS, AND IT WAS VISIBLE IMMEDIATELY AFTER THE SENSOR REMOVAL. THE PATIENT PASSED AWAY, BUT IT WAS NOT RELATED TO THE SENSOR.

  Patient problems: Insufficient Information

  MAUDE report 19706366 ↗
• InjuryJul 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, SKIN BURNS WERE FOUND IN THE AREAS WHERE THE SENSORS WERE USED, SPECIFICALLY THE LEFT FRONTAL REGION AND THE RIGHT ILIAC. THE SENSOR REMAINED AT THE SITE OF THE SKIN INTEGRITY PROBLEM FOR AT MOST EIGHT DAYS, AND THE BURN WAS VISIBLE IMMEDIATELY AFTER THE SENSOR WAS REMOVED. THE PATIENT PASSED AWAY, BUT IT WAS NOT RELATED TO THE SENSOR.

  Patient problems: Insufficient Information

  MAUDE report 19704772 ↗
• MalfunctionJun 29, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAS BEEN CONNECTED AND MONITORED WITH THE DEVICE. ONE SENSOR ON THE FOREHEAD AND ONE ON THE LOWER BACK TO MONITOR THE KIDNEYS ONCE ARRIVED TO THE NICU. THE SKIN WAS CLEANED WITH DISINFECTANT SOLUTION BEFORE APPLICATION. THE PATIENT HAD SHOWN A REACTION TO THE SENSORS. NOT ESTABLISHED YET WHETHER THIS WAS PRESSURE SORES OR KIND OF BURNS, BUT IT WAS A RED/PURPLE DISCOLORATION OF THE SKIN, THE DEMARCATION WAS EXACTLY LIKE THE SHAPE OF THE SENSOR. THE SENSOR SITE WAS CHECKED TO ASSURE THAT IT'S STILL IN THE RIGHT POSITION, THE SKIN AROUND THE SENSOR WAS NORMAL, BUT THE PROBLEM WAS UNDERNEATH THE SENSOR. IT WAS PLACED FOR 8 DAYS BEFORE THE STAFF NOTICED THE DISCOLORATION. THE PATIENT WAS SUPINE MOST OF THE TIME, BUT PATIENT WAS POSITIONED ON HIS SIDE FOR A SHORT PERIOD OF TIME. THE TREATMENT WAS FREQUENT REPOSITION OF THE PATIENT (MORE PRONE TIME) UNTIL THE DISCOLORATION IMPROVED. HOWEVER, THE PATIENT HAD IMPROVED DRAMATICALLY. THE PATIENT HAD NOT BEEN RECONNECTED WITH SENSORS AND AS MENTIONED THE FOREHEAD AND LOWER BACK HAVE IMPROVED.

  Patient problems: Burn(s)

  MAUDE report 17228004 ↗
• MalfunctionJun 7, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAS BEEN CONNECTED AND MONITORED WITH THE DEVICE. ONE SENSOR ON THE FOREHEAD AND ONE ON THE LOWER BACK TO MONITOR THE KIDNEYS ONCE ARRIVED TO THE NICU. THE SKIN WAS CLEANED WITH DISINFECTANT SOLUTION BEFORE APPLICATION. THE PATIENT HAD SHOWN A REACTION TO THE SENSORS. NOT ESTABLISHED YET WHETHER THIS WAS PRESSURE SORES OR KIND OF BURNS, BUT IT WAS A RED/PURPLE DISCOLORATION OF THE SKIN, THE DEMARCATION WAS EXACTLY LIKE THE SHAPE OF THE SENSOR. THE SENSOR SITE WAS CHECKED TO ASSURE THAT IT'S STILL IN THE RIGHT POSITION, THE SKIN AROUND THE SENSOR WAS NORMAL, BUT THE PROBLEM WAS UNDERNEATH THE SENSOR. IT WAS PLACED FOR 8 DAYS BEFORE THE STAFF NOTICED THE DISCOLORATION. THE PATIENT WAS SUPINE MOST OF THE TIME, BUT PATIENT WAS POSITIONED ON HIS SIDE FOR A SHORT PERIOD OF TIME. THE TREATMENT WAS FREQUENT REPOSITION OF THE PATIENT (MORE PRONE TIME) UNTIL THE DISCOLORATION IMPROVED. HOWEVER, THE PATIENT HAD IMPROVED DRAMATICALLY. THE PATIENT HAD NOT BEEN RECONNECTED WITH SENSORS AND AS MENTIONED THE FOREHEAD AND LOWER BACK HAVE IMPROVED.

  Patient problems: Burn(s)

  MAUDE report 17080303 ↗