Invos 5100C-EURecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521211179), received between Nov 29, 2017 and Dec 11, 2024 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Low Readings” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Failure to Analyze Signal; Low Readings; Failure to Analyze Signal; Low Readings

  IT WAS REPORTED THAT THE UNIT HAD NO RSO2 READING WHEN ATTEMPTED TO USE, THE SENSORS WERE CONNECTED IN ORDER ACCORDING TO THE FLASHING CABLES. THE RIGHT SIDE HAD A GOOD CONNECTION BUT HAD A STRUGGLE WITH THE LEFT SIDE. IT WAS TRIED DISCONNECTING NUMEROUS TIMES, RESTATING THE CONSOLE AND TWO NEW SENSOR PROBES, USED AN ABRASIVE WIPE TO ROUGH UP THE FOREHEAD, BUT THE SAME OUTCOME. THEN, ENDED P CONNECTING OTHER DEVICE WHERE, READINGS WERE ON THE LOWER SIDE 50 AND RIGHT SIDE WAS 60. UPON, TESTING THE REPORTED UNIT ON A STAFF MEMBER AFTER PROCEDURE, A READING WAS POSSIBLE ON LEFT SIDE BUT QUITE LOW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901477 ↗
• MalfunctionDec 9, 2024Display or Visual Feedback Problem; Incorrect Measurement; Failure to Power Up; Use of Device Problem; Display or Visual Feedback Problem; Incorrect Measurement; Failure to Power Up; Use of Device Problem

  IT WAS REPORTED THAT THE MONITOR'S BUTTONS COULD NOT SELECT WELL AND THE SCREEN WENT ON AND OFF. ADDITIONALLY, THE DEVICE DID NOT DISPLAY THE BASELINE CORRECTLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20878584 ↗
• MalfunctionNov 27, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT INCORRECT VALUES WERE OBSERVED IN ASSOCIATION WITH THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800838 ↗
• MalfunctionNov 7, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE MONITOR HAD INCORRECT READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20627429 ↗
• MalfunctionAug 8, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Erratic or Intermittent Display; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD NO SATURATION MEASUREMENT DESPITE A CHANGE IN PATIENT CABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937871 ↗
• MalfunctionJul 18, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE PRODUCT GAVE LOW READINGS ON CHANNEL 2. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19774395 ↗
• MalfunctionMay 23, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE PRODUCT GAVE LOW READINGS. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387739 ↗
• MalfunctionFeb 23, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE PATIENT'S FOREHEAD HAD "PHOTOBURN" LOW-TEMPERATURE BURNS CAUSED BY LIGHT SOURCES AFTER APPROXIMATELY ONE HOUR OF USE. THERE WERE MARKS ON THE SKIN SURFACE BUT NOT DAMAGED. SENSOR STAYED IN PLACE MORE THAN AN HOUR SURGICAL TIME. NEW SENSOR, VISCOSITY WAS SUFFICIENT WITHOUT APPLYING ADDITIONAL FORCE. THE SKIN OF THE CHILD WAS DELICATE, SO USED WET WIPES TO SIMPLY CLEAN THE SKIN. AFTER REMOVAL OF THE SENSOR, THE SKIN WAS INTACT WITH RED MARKS AND IN SUPINE POSITION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18767958 ↗
• MalfunctionFeb 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD SKIN DAMAGE DUE TO SENSOR USE. THE LENGTH OF THE BURN SITE WAS ABOUT 6 MM AND 3 MM, AND THE DEPTH OF THE BLISTER WAS ABOUT 1 MM AFTER BREAKAGE. THE SENSOR WAS ON THE SKIN FOR 3.5 HOURS BETWEEN ADHESIVES DURING SURGERY. THE SENSOR WAS STAMPED WHEN IT WAS REMOVED, AND THE NEXT DAY THE STAMP WAS BLISTERED. THE SKIN INTEGRITY ISSUE LASTED FOR ABOUT 10 HOURS. A DERMATOLOGIST WAS CONSULTED THE DAY AFTER THE DISCOVERY OF BLISTERS, AND THE FEEDBACK WAS LOW TEMPERATURE BURNS. DERMATOLOGY RECOMMENDED OINTMENT TREATMENT. THE PATIENT WAS TRANSFERRED FROM THE INTENSIVE CARE UNIT (ICU) TO THE GENERAL WARD AND WAS NOT DISCHARGED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18691152 ↗
• MalfunctionJun 20, 2023Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, A RETROSPECTIVE COHORT STUDY WAS CONDUCTED ON PATIENTS WITH AN ADMISSION DIAGNOSIS OF CARDIOGENIC SHOCK WHO SUBSEQUENTLY REQUIRED VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) SUPPORT AT A TERTIARY INTENSIVE CARE UNIT (ICU) BETWEEN APRIL 2009 AND DECEMBER 2018. VENOUS BLOOD SAMPLES WERE TAKEN FROM THE ECMO CIRCUIT PRE-OXYGENATOR, ARTERIAL SAMPLES FROM THE PATIENT¿S RIGHT RADIAL ARTERIAL LINE (WITHIN 10 MINUTES OF EACH OTHER). ALL MEASUREMENTS IN THIS STUDY WERE CONDUCTED 24¿36 HOURS AFTER INITIATING VA-ECMO SUPPORT AND IN THE FINAL 24 HOURS OF VA-ECMO SUPPORT BEFORE SUCCESSFUL WEANING OR A DECISION TO WITHDRAW ECMO SUPPORT. BETWEEN APRIL 2009 AND DECEMBER 2018, A TOTAL OF 207 PATIENTS RECEIVED VV OR VA-ECMO. ONE HUNDRED SEVENTY-SIX PATIENTS DID NOT MEET THE INCLUSION CRITERIA. THIRTY ONE PATIENTS WITH CARDIOGENIC SHOCK WERE INCLUDED FOR REVIEW, OF WHICH 16 (52%) SURVIVED, WHILE 15 (48%) DIED, PRIMARILY DUE TO MULTI-ORGAN FAILURE. ONE PATIENT IN THE SURVIVOR GROUP DIED 4 DAYS POST-ECMO. THIS PATIENT WAS PLACED ON ECMO FOR CARDIOGENIC SHOCK (DECOMPENSATED DILATED CARDIOMYOPATHY) AND AFTER 8 DAYS OF SUPPORT WAS SUCCESSFUL

  Patient problems: Insufficient Information

  MAUDE report 17162272 ↗
• MalfunctionMar 9, 2023Use of Device Problem; Device Damaged Prior to Use; Low Readings; Material Split, Cut or Torn; Device Fell; Use of Device Problem; Device Damaged Prior to Use; Low Readings; Material Split, Cut or Torn; Device Fell

  ACCORDING TO THE REPORTER, DURING USE, THE MONITOR HAD LOW RSO2, IT WAS 20% LOWER THAN THE SET THRESHOLD. THE FRONT AND BACK CASING AND HANDLE WERE DAMAGED. THE PREAMPLIFIER HOUSING WAS CRACKED ON BOTH UPPER AND LOWER SIDES. THE CABLE CONNECTION TO THE MONITOR HAD A RUPTURED ENCLOSURE. THE DISPLAY HAD A DAMAGED LOWER LEFT CORNER AND WORN KEYPAD. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16513088 ↗
• MalfunctionApr 18, 2022Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE DID NOT ALARM AND THE SENSOR'S ADHESIVE WEAKENED AND WHEN THE SENSOR WAS REMOVED, A PRESSURE SORE WAS DETECTED ON THE SPOT. THE PATIENT WAS GIVEN OINTMENT FOR IRRITATION RELIEF AND PRESSURE BANDAGE. THE DURATION OF THE SENSOR ON THE PATIENT WAS 10 DAYS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 14137729 ↗
• MalfunctionJan 28, 2022Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE CHILD'S BACK BURNED BY THE SENSOR AFTER LONG SURGERY (LIVER TRANSPLANT, 12 HOURS). EITHER A PRESSURE ULCER OR A SENSOR BURN BECAUSE UNFORTUNATELY THE LESION WAS DISCOVERED A FEW DAYS AGO. THE PATIENT HAD BURNED.

  Patient problems: Burn(s); Insufficient Information

  MAUDE report 13386366 ↗
• MalfunctionSep 9, 2021High Readings; High Readings

  ACCORDING TO THE REPORTER, THE NEWBORN PATIENT WAS MONITORED CEREBRALT WITH THE UNIT AND SENSORS. THE VALUE WAS FLAT ON 95 DURING PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451043 ↗
• MalfunctionJun 22, 2021Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING AN OPEN HEART SURGERY, WHILE THE PATIENT WAS ON THE HEART-LUNG BYPASS MACHINE, THE HCP'S NOTICED A BILATERAL DECLINE IN RSO2 READING, WITH NO SPECIFIC REASON. ACTIONS WERE TAKEN LIKE DEEPER INDUCTION, HIGHER FLOW RATE EXTENSION AND A MILD IMPROVEMENT WAS SEEN. HCP DECIDED TO SWITCH TO A DIFFERENT RSO2 DEVICE, SHOWED A HIGHER BASE LINE VALUE 61-56 (CASMED) VS 42-36 (INVOS). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041572 ↗
• MalfunctionNov 20, 2020Erratic or Intermittent Display; Failure to Analyze Signal; Use of Device Problem; High Readings; Erratic or Intermittent Display; Failure to Analyze Signal; Use of Device Problem; High Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD A READING ISSUES (ERRATIC AND HIGH READINGS). ALSO, THE KEYPAD WAS FOUND TO BE FAULTY. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10875315 ↗
• MalfunctionSep 15, 2020High Readings; High Readings

  ACCORDING TO THE REPORTER, THE UNIT'S VALUE WAS NOT ACCURATE COMPARE TO ANOTHER UNIT, IT WAS HIGHER THAN THE EXPECTED READING. ANOTHER EQUIPMENT WAS USED TO CONFIRM AND IT SHOWED THE EXPECTED VALUES ON THAT DEVICE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10538396 ↗
• MalfunctionOct 25, 2019Device Alarm System; Incorrect Measurement; Device Alarm System; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE DEVICE'S VALUES WERE NOT CONGRUENT WITH THE ACTUAL STATE OF THE PATIENT. IT WAS REPORTED THAT IT DID NOT GIVE ALARM WHEN THE VALUES WERE NOT IN THE RANGE. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9242277 ↗
• MalfunctionAug 7, 2019Device Emits Odor; Device Emits Odor

  ACCORDING TO THE REPORTER, THE UNIT CONNECTOR SPARKED. IT WAS REPORTED THAT THERE WAS A BURNING DAMAGE ON SEVERAL PARTS. IT WAS INDICATED THAT THERE WAS A LITTLE SMOKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 8869718 ↗
• MalfunctionDec 28, 2018Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING SETUP, THE UNIT HAD LOW READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8204625 ↗
• MalfunctionMay 2, 2018False Reading From Device Non-Compliance; False Reading From Device Non-Compliance

  ACCORDING TO THE REPORTER, THE DEVICE HAD ERRATIC READINGS. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7481056 ↗
• MalfunctionNov 29, 2017High Readings; High Readings

  MEDTRONIC RECEIVED REPORT THAT THE UNIT'S SATURATION RATE WAS HIGH ON THE RIGHT SIDE. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068462 ↗