INVOS 5100C-PARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521145573), received between Sep 5, 2017 and Jul 8, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE UNIT DID NOT READ CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438225 ↗
• MalfunctionMar 3, 2025High Readings; High Readings

  IT WAS REPORTED THAT DURING SERVICING, THERE WERE HIGH READINGS IN OXIMETRY ASSOCIATED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510242 ↗
• MalfunctionNov 27, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT A DEVICE MALFUNCTION OCCURRED WITH THE PRODUCT, LEADING TO INCORRECT VALUES BEING DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801045 ↗
• MalfunctionNov 6, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT DID NOT MEASURE CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622582 ↗
• MalfunctionNov 5, 2024Incorrect Measurement; Device Damaged Prior to Use; Ambient Noise Problem; Incorrect Measurement; Device Damaged Prior to Use; Ambient Noise Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE'S VALUE WAS INCORRECT. IT WAS SAME AS SIMULATOR, AND THE COVER WAS BROKEN AND HAD A NOISE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612980 ↗
• MalfunctionNov 4, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE DEVICE HAD NO RELIABLE READINGS. IT DID NOT MEASURE CORRECTLY EVEN WHEN TRENDING TERMINALS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20605644 ↗
• MalfunctionAug 5, 2024Incorrect Measurement; Incorrect Measurement

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

  Patient problems: Insufficient Information

  MAUDE report 19905058 ↗
• MalfunctionJul 25, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD LOW READINGS ON CHANNEL TWO. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828718 ↗
• MalfunctionNov 15, 2023Device Alarm System; Failure to Analyze Signal; Device Alarm System; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, DURING TESTING, THE UNIT WAS NOT READING, NO ALARMS OR ERROR CODES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145785 ↗
• MalfunctionAug 28, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE GAVE LOW RSO2 VALUE OF 15. THEY CHANGED THE CANNULA TO LARGER SIZE AND USED INOTROPES TO MANAGED BLOOD PRESSURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940300 ↗
• MalfunctionApr 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD A LOW READING. IT WAS REPORTED THAT READING VALUES RANGES AT 10, 20 AND 45 THEN NO READING AT ALL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8555580 ↗
• 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 8204626 ↗
• MalfunctionAug 21, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD BAD SIGNAL AND DEFECTIVE CONNECTION TO PREAMP. CUSTOMER INDICATED THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801654 ↗
• MalfunctionJun 5, 2018False Reading From Device Non-Compliance; Incorrect, Inadequate or Imprecise Result or Readings; False Reading From Device Non-Compliance; Incorrect, Inadequate or Imprecise Result or Readings

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE HAD A READING ISSUE: THE VALUE OF AROUND 40 WHICH APPEARED ON THE MONITOR DID NOT MATCH WITH THE CURVE AROUND 80. THE CUSTOMER REPORTED NO PATIENT HARM.

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

  MAUDE report 7568628 ↗
• MalfunctionSep 5, 2017Low Readings; Low Readings

  MEDTRONIC RECEIVED REPORT THAT THE INVOS 5100C PREAMPLIFIER PROVIDED LOW READINGS FROM THE SECOND CHANNEL. THERE IS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6841738 ↗