INVOS 5100C-PBRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521145580), received between Dec 28, 2018 and Jan 31, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (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.

• MalfunctionJan 31, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE GAVE LOW VALUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618925 ↗
• MalfunctionJan 5, 2024Incorrect Measurement; Incorrect Measurement

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

  Patient problems: Insufficient Information

  MAUDE report 18455045 ↗
• MalfunctionNov 17, 2023Device Alarm System; Image Display Error/Artifact; Failure to Analyze Signal; Device Alarm System; Image Display Error/Artifact; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT WAS NOT READING. THERE WERE NO ALARMS OR ERROR CODES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166252 ↗
• MalfunctionNov 17, 2023Device Alarm System; Failure to Analyze Signal; Communication or Transmission Problem; Device Alarm System; Failure to Analyze Signal; Communication or Transmission Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT WAS NOT READING. THERE WERE NO ALARMS OR ERROR CODES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161558 ↗
• MalfunctionNov 15, 2023Device Alarm System; Failure to Analyze Signal; Device Alarm System; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT WAS NOT READING. THERE WERE NO ALARMS OR ERROR CODES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144678 ↗
• MalfunctionAug 15, 2023Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, OCCURRED PRE-OPERATIVELY, THE MAIN CABLE OF THE UNIT WAS DAMAGED AND BURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553235 ↗
• 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 13386441 ↗
• 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 8204653 ↗