INVOS 5100C-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521211193), received between Jul 25, 2018 and Nov 10, 2024 — classified as 1 death, 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Low Readings” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2024Failure to Analyze Signal; Low Readings; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD CONSTANT READING OF 15 OR NO READING. CUSTOMER WAS INSTRUCTED TO APPLY SENSOR TO HIMSELF AND IT FUNCTIONED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649227 ↗
• MalfunctionAug 12, 2024Erratic or Intermittent Display; High Readings; Low Readings; Erratic or Intermittent Display; High Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE MONITOR WAS PRODUCING LOW AND HIGH READINGS. THE SENSORS AND CABLES WERE SWAPPED ON TWO OTHER MONITORS; THERE WERE ONLY ERRATIC READINGS ON THE REPORTED MONITOR, AND BASIC INTERFERENCES WERE RULED OUT. IT WAS ALSO CONFIRMED THAT THE MONITOR HAD NO WATER DAMAGE AND HAD THE LATEST SOFTWARE VERSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959970 ↗
• MalfunctionMay 24, 2024Device Alarm System; Failure to Analyze Signal; Communication or Transmission Problem; No Apparent Adverse Event; Device Alarm System; Failure to Analyze Signal; Communication or Transmission Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, PRIOR TO USE, NO VALUES WERE OBSERVED ON THE MONITOR AFTER SEVERAL PREAMPLIFIERS WERE ATTACHED. WHEN THE PREAMPLIFIERS WERE ATTACHED TO OTHER MONITORS, IT ALL WORKED. AFTER APPLYING NEW SENSORS, THE MONITOR FINALLY READ THE VALUES, THUS THE ISSUE WAS RESOLVED. THE MONITOR WILL NOT BE RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397265 ↗
• MalfunctionFeb 5, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW OR INACCURATE READINGS. TROUBLESHOOTING FOR THE SENSOR WAS PROVIDED TO THE CUSTOMER VIA EMAIL. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME

  Patient problems: Insufficient Information

  MAUDE report 18639095 ↗
• InjuryJan 25, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD A SCREEN PROBLEM, IT PRESENTED LINES AND FRAY ENSURE. THERE WAS PATIENT INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16240802 ↗
• MalfunctionJan 3, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WERE SEVERE BURNS ON PATIENT WHERE THE SENSORS WERE PLACED.

  Patient problems: Burn(s)

  MAUDE report 16089785 ↗
• MalfunctionDec 20, 2021Defective Component; Temperature Problem; Defective Component; Temperature Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S POWER SUPPLY DROPPED AND COULD NOT BE RESTARTED. THEN, IT STARTED TO SMELL BURNT FROM THE BACK. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 13042682 ↗
• MalfunctionNov 17, 2021Failure to Power Up; Temperature Problem; Failure to Power Up; Temperature Problem

  ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT TURN ON, LEFT TO CHARGE, AND UNIT STARTED SMOKING WHEN POWERED ON. THE USER REMOVED BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12825639 ↗
• MalfunctionMay 14, 2021Failure to Analyze Signal; Low Readings; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD LOW TO NO SPO2 READINGS. TEST USING FIELD TEST DEVICE, RECEIVED LOW TO NO READING WHILE IN THE EXAM ROOM. HOOKED UP ANOTHER DEVICE AND IT WORKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828390 ↗
• MalfunctionOct 15, 2020Failure to Power Up; Failure to Power Up

  ACCORDING TO THE REPORTER, THE UNIT WAS POWERING DOWN ON ITS OWN. THE UNIT BOOTING IT UP AND DOWN, VERIFIED THE FLASH DRIVE, AND SWAPPED OUT THE DRIVE TO ISOLATE THE FAILURE. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DEVICE WAS PHYSICALLY BURNT. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 10683577 ↗
• MalfunctionMay 26, 2020Failure to Shut Off; Temperature Problem; Failure to Shut Off; Temperature Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS BURNED AND HAD SMOKING ODOR. IT WAS ALSO REPORTED THAT IT WOULD NOT TURN OFF. HAD TO UNPLUG AND REMOVE THE BATTERY TO GET THE DEVICE STOP BURNING. TROUBLESHOOTING ISOLATED THE ISSUE ON THE DEVICE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10086133 ↗
• MalfunctionJan 28, 2020Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE GAVE LOW READINGS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 9639136 ↗
• DeathNov 4, 2019Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE UNIT WOULD NOT OPERATE ON BATTERY. THE UNIT PLUGGED ON AC WAS WORKING PROPERLY ON A PATIENT WHEN THE PATIENT EXPIRED. THE ISSUE OF THE UNIT NOT RUNNING ON BATTERY WAS FOUND AFTER THE PATIENT EXPIRED. THE PATIENT DID NOT PASSED AWAY DUE TO THE ISSUE.

  Patient problems: Death

  MAUDE report 9272759 ↗
• InjuryJul 25, 2018Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, AN INFANT PATIENT RECEIVED PRESSURE INJURIES ON THE SKIN FROM THE SENSORS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pressure Sore/Ulcer; Skin Irritation

  MAUDE report 7720757 ↗