INVOS PM7100 (UDI 10884521552609)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521552609), received between Mar 12, 2019 and May 23, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Low Readings” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K182868, K211561); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Incorrect Measurement; Unable to Obtain Readings; Incorrect Measurement; Unable to Obtain Readings

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

  Patient problems: Insufficient Information

  MAUDE report 19387668 ↗
• MalfunctionOct 12, 2023Display or Visual Feedback Problem; Image Display Error/Artifact; High Readings; Display or Visual Feedback Problem; Image Display Error/Artifact; High Readings

  ACCORDING TO THE REPORTER, THE MONITOR SCREEN WENT SUDDENLY GRAY WITH A SYSTEM ERROR IN THE MIDDLE OF THE ONGOING SURGERY. THE NURSE ANESTHETIST INVOLVED COULD NOT TELL WHAT ERROR MESSAGE WAS GIVEN. THE PROBLEMS OCCURRED DURING HYPOTHERMIC CIRCULATORY ARREST AND CAUSED A MASSIVE DELAY IN OPERATING TIME. REPLACING THE ENTIRE SYSTEM WAS ALSO UNSUCCESSFUL, AS THIS MONITORING SYSTEM ALSO SUDDENLY FAILED. THERE WERE REPORTS REGARDING INCOMPREHENSIBLE AND INCORRECT HIGH RSO2 VALUES AND A SUDDEN CHANGE ON THE SCREEN FROM 2 TO 4 CHANNELS. THE NURSE ANESTHETIST NOTICED THAT THERE WAS A LOT OF CAUTERY IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 17921321 ↗
• MalfunctionOct 12, 2023Display or Visual Feedback Problem; Image Display Error/Artifact; High Readings; Display or Visual Feedback Problem; Image Display Error/Artifact; High Readings

  ACCORDING TO THE REPORTER, THE MONITOR SCREEN WENT SUDDENLY GRAY WITH A SYSTEM ERROR IN THE MIDDLE OF THE ONGOING SURGERY. THE NURSE ANESTHETIST INVOLVED COULD NOT TELL WHAT ERROR MESSAGE WAS GIVEN. THE PROBLEMS OCCURRED DURING HYPOTHERMIC CIRCULATORY ARREST AND CAUSED A MASSIVE DELAY IN OPERATING TIME. REPLACING THE ENTIRE SYSTEM WAS ALSO UNSUCCESSFUL, AS THIS MONITORING SYSTEM ALSO SUDDENLY FAILED. THERE WERE REPORTS REGARDING INCOMPREHENSIBLE AND INCORRECT HIGH RSO2 VALUES AND A SUDDEN CHANGE ON THE SCREEN FROM 2 TO 4 CHANNELS. THE NURSE ANESTHETIST NOTICED THAT THERE WAS A LOT OF CAUTERY IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 17921103 ↗
• MalfunctionJul 31, 2020Failure to Analyze Signal; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, DURING A HEART SURGERY PROCEDURE, THE DEVICE HAD READINGS AT THE BEGINNING BUT SUDDENLY STOPPED GIVING READINGS. THE SENSORS HAD TO BE DISCONNECTED AND RECONNECTED TO GET RSO2 VALUE AGAIN. THE EVENT INVOLVED SEVERAL PATIENTS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 10350761 ↗
• InjuryNov 19, 2019High Readings; Low Readings; High Readings; Low Readings

  ACCORDING TO THE REPORTER, THE RSO2 VALUES JUMPED SIGNIFICANTLY UP AND DOWN. THE PATIENT WAS ALIVE BUT IN BAD SHAPE.

  Patient problems: Injury

  MAUDE report 9345692 ↗
• MalfunctionMay 17, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD LOW RSO2 READING. IT WAS REPORTED THAT OVER A PERIOD OF ABOUT 10 MINUTES THERE WERE ERRATIC CHANGES IN THE VALUES FOR BOTH, LEFT AND RIGHT, HEMISPHERES,VALUES DROPPED TO NEARLY 25% ABSOLUTE. THE PROCEDURE WAS ACCOMPLISHED WITHOUT PROBLEMS AND NO INJURY FOR THE PATIENT.

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

  MAUDE report 8622069 ↗
• MalfunctionApr 18, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE SHOWED "SIGNAL ERROR DETECTED" AND THE RSO2 VALUES THE LOWER OR WERE NOT SHOWN. IT WAS INDICATED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527657 ↗
• MalfunctionMar 14, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICES HAD READING ISSUE. IT WAS STATED THAT THE MONITOR SHOWED LOW BASELINE AND ERRATIC RSO2 READING FLUCTUATING BY 40-50% FROM BASELINE UNILATERALLY AND ON BOTH SIDES. IT WAS STATED THAT FIRST BASELINES WERE 20 AND 24. SENSORS WERE REMOVED AND NEW ONES APPLIED RESULTING IN BASELINES OF 28 AND 30. BASELINES READING WERE SET ON AN AWAKE PATIENT RECEIVING 6 LPM OF OXYGEN. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INJURY.

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

  MAUDE report 8422580 ↗
• MalfunctionMar 12, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD A LOW SPO2 READING. THE CUSTOMER INDICATED NO PATIENT OR STAFF IMPACT.

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

  MAUDE report 8414394 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182868, K211561. One submission often covers many models, so check the product and lot details in each record.

• Z-1731-2024 · Jan 9, 2024 · Open, Classified
  Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
• Z-1732-2024 · Jan 9, 2024 · Open, Classified
  Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC