INVOS PMSENS71-A (UDI 10884521556959)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521556959), received between Apr 18, 2019 and Apr 24, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Low Readings” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K182868); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, SENSOR HAD LOW RS02 READINGS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173635 ↗
• MalfunctionApr 16, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Erratic or Intermittent Display; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, DURING A "CORONARY ARTERY BYPASS WARM BEATING ," THE SENSOR HAD ERRATIC RSO2 READINGS FROM BELOW 15 TO 50S OR NO READINGS. THE MONITOR, PREAMPLIFIER, AND CABLES WERE SWAPPED OUT, BUT THE SENSOR CONTINUED TO READ ERRATICALLY. THE PERFUSIONIST PLACED THE SENSOR ON THEMSELVES AND GOT NORMAL SOMATIC READINGS WITH NO ISSUES. THE PATIENT COULD NOT BE MONITORED, AND THERE WAS A DELAY IN THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19121473 ↗
• MalfunctionApr 1, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR'S RSO2 READING SHOWED A VALUE OF 45 AND MORE VARIATION THAN THE EXPECTED VALUES IN 60S AND 30S. THE REUSABLE SENSOR CABLE AND PREAMP WAS SWAPPED AND NO VALUES WERE CHANGED ON PATIENT. TROUBLESHOOTING HAD LACKED OF CHANGED POINT TO THE SENSOR. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19012975 ↗
• MalfunctionJun 14, 2022Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE GAVE LOW RSO2 VALUE OF 15. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 14688972 ↗
• MalfunctionApr 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING AN IN-SERVICE DEMONSTRATION AT THE HOSPITAL BY A MEDTRONIC REPRESENTATIVE, THE SENSOR WAS USED AND LATER THE REPRESENTATIVE REPORTED A SKIN INTEGRITY ISSUE AFTER THE SENSORS HAD BEEN APPLIED. THE SENSORS WERE DISCARDED AFTER THE DEMONSTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164065 ↗
• MalfunctionApr 14, 2021Low Readings; Low Readings

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE SHOWED ABOUT 10 POINTS LOWER RSO2 READINGS THAN THE PREVIOUS MODEL AFTER ABOUT 30 MINUTES OF USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11664315 ↗
• MalfunctionJul 31, 2020Image Display Error/Artifact; Failure to Analyze Signal; Image Display Error/Artifact; 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. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10350727 ↗
• MalfunctionMar 20, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING AN IN-SERVICE DEMONSTRATION AT THE HOSPITAL BY A MEDTRONIC REPRESENTATIVE, THE SENSOR WAS USED AND LATER THE REPRESENTATIVE REPORTED A SKIN INTEGRITY ISSUE AFTER THE SENSORS HAD BEEN APPLIED. THE SENSORS WERE DISCARDED AFTER THE DEMONSTRATION.

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

  MAUDE report 9859451 ↗
• MalfunctionOct 14, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS PLACED ON THE DOCTOR'S FOREARM FOR A DEMO FOR ABOUT 20 MINUTES, IT CAUSED CONTACT DERMATITIS FROM SENSOR APPLICATION/REMOVAL DUE TO SOME MEDICAL ADHESIVE ALLERGIES. THERE IS NO MEDICAL TREATMENT NEEDED REPORTED BUT THERE WAS PERSISTENCE OF RASH ON THIRD POST-APPLICATION DAY DESPITE TREATMENT WITH TOPICAL STEROID CREAM AND ORAL ANTIHISTAMINE.

  Patient problems: Rash

  MAUDE report 9187096 ↗
• MalfunctionMay 16, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD LOW RSO2 READING. 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 8617083 ↗
• 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 8529804 ↗

Recalls under the same FDA submission

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

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