INVOS CNN/SNN (UDI 20884521106229)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20884521106229), received between May 10, 2018 and Mar 29, 2022 — classified as 1 death, 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR'S ADHESIVE WEAKENED AND WHEN THE SENSOR WAS REMOVED, A PRESSURE SORE WAS DETECTED ON THE SPOT. THE DURATION OF THE SENSOR ON THE PATIENT WAS 10 DAYS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 13940176 ↗
• MalfunctionApr 21, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CAUSED BRUISING TO PATIENT'S FOREHEAD. IT WAS REPORTED THAT THE BRUISE WAS GETTING MUCH BETTER AND ALMOST DISAPPEARED, AND THIS DID NOT CAUSE ANY PERMANENT DAMAGE TO THE SKIN.

  Patient problems: Bruise/Contusion; Ecchymosis

  MAUDE report 11700316 ↗
• InjuryJun 4, 2020Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, A PRETERM BABY WHO WAS BORN ON 29+1 WEEKS, WAS TRANSFERRED TO NICU, AND SHE WAS RECRUITED TO A STUDY WHERE SHE HAD ADDITIONAL MONITORING WITH THE DEVICE. THE SENSOR WAS TAKEN OFF ONCE A DAY TO AIR THE SKIN UNDER IT AND A SPECIFIC ADHESIVE REMOVER WAS USED TO MAKE SURE THAT THE BABY¿S SKIN WOULD NOT BE HARMED. BUT ON THE THIRD DAY, IT WAS NOTICED THAT THERE WERE TWO DARK SPOTS ON HER FOREHEAD, RIGHT WHERE THE SENSOR HAD THE ELECTRODES, AND THOSE SPOTS TURNED OUT TO BE NECROTIC. THE MONITORING WAS FINISHED AT THAT POINT AND THE SENSOR WAS REMOVED ALTOGETHER, AND THE BABY¿S SKIN WAS TENDED WITH MEDICAL HONEY IN ACCORDANCE WITH THE NICU¿S INSTRUCTIONS. IT TOOK QUITE A FEW WEEKS FOR THE SKIN TO HEAL, BUT IS NOW OK.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 10121142 ↗
• MalfunctionSep 18, 2019Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem; Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DEVICE SENSOR PLACED ON THE FOREHEAD SEEMED TO MAKE MINIMAL BURNS ON THE SKIN (DISCOLORATION) AND WAS NOT MADE A CONCERN AS THE BURN CAUSED BY THE RENAL SENSOR HAD CAUSED HAVOC IN THE UNIT. THE END-USERS ARE UNHAPPY WITH THE PRODUCT BECAUSE OF THE IRRITATION AND BURN CAUSED TO THIS PATIENT., PATIENT WAS ALIVE WITH THE SENSOR BURNT THE SKIN SURFACE OF THE INFANT (SUPERFICIAL TO 1ST DEGREE).

  Patient problems: Burn(s)

  MAUDE report 9083529 ↗
• DeathApr 18, 2019Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE SENSOR WAS WORKING AND WAS LEFT FOR FIVE DAYS. IT WAS REPORTED THAT WHEN THE PROBE WAS REMOVED THEY DISCOVERED A VERY RED FOREHEAD. THE PROBE WAS LEFT OFF AND HYDROMOL WAS APPLIED. THE PATIENT WAS DECEASED BUT THE SENSOR WAS NOT THE CAUSE OF DEATH. THE SENSOR WAS LEFT ON FOR TOO LONG. IT WAS EXPLAINED THAT THE SENSORS ARE EXPENSIVE AND THIS IS WHY THE SENSORS ARE NOT CHANGED EVERY 24 HOURS. THE REPORTER STATED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8528345 ↗
• InjuryDec 20, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE NEW NEONATAL NEAR-INFRARED SPECTROSCOPY (NIRS) SENSORS HAD RELATED PRESSURE INJURY ON THE FLANK OF AN INFANT DUE TO THE CORD THAT IS ATTACHED TO THE SENSOR. IT WAS REPORTED THAT IT IS MUCH HARDER AND LESS FLEXIBLE. THE CUSTOMER INDICATED THAT THERE WAS PATIENT INVOLVEMENT WITH INJURY.

  Patient problems: Injury

  MAUDE report 8186127 ↗
• InjuryJun 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE PATIENT SUFFERED A BURN ULCER WITH HEMORRHAGIC BLISTERS. IT WAS INDICATED THAT THE PATIENT HAD AN INFECTION AND NEEDED TO BE INTUBATED.

  Patient problems: Injury

  MAUDE report 7591960 ↗
• InjuryMay 10, 2018Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE SENSOR CAUSED A 0.5CM X 0.5 CM BURN ON THE FRONTAL AREA OF A PREMATURE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 7504419 ↗