INVOS PM7100 (UDI 10884521810105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884521810105), received between Oct 19, 2023 and Aug 21, 2025 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Low Readings” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Incorrect Measurement; Material Split, Cut or Torn; Incorrect Measurement; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE MONITOR CABLE WAS DAMAGED AND DID NOT READ CORRECTLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22860037 ↗
• MalfunctionJun 27, 2025Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem; Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING USE, THE MONITOR WAS NOT DETECTING THE SENSOR CONNECTED ON A PATIENT, OR WAS ONLY DETECTING ONE SIDE. THE ISSUE WAS OBSERVED WITH A BRAND NEW MONITOR. A NEW MONITOR WAS USED, AND THERE WAS NO ISSUE WITH THE REPLACEMENT. THERE WAS UNSPECIFIED PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22347350 ↗
• MalfunctionFeb 3, 2025Failure to Power Up; Temperature Problem; Failure to Power Up; Temperature Problem

  IT WAS REPORTED THAT DURING USE, THE CIRCULATING NURSE WENT TO TRY AND FIGURE OUT WHY THE MONITOR SHUT DOWN AND NOTICED THAT THE EQUIPMENT WAS VERY HOT. WHEN THE NURSE TOOK THE MONITOR OUT OF THE HOUSING UNIT, IT WAS OBSERVED THAT THE PRONGS HAD MELTED AND THE BASE WAS WET. ADDITIONALLY, THE RESIDUE AND LIQUID INSIDE THE MONITOR CAUSED A SHORT CIRCUIT, A SMALL FIRE, AND SMOKE. THE CLEANING FLUID RAN DOWN INTO THE CHARGING CONNECTOR BETWEEN THE BASE AND THE DEVICE. IT WAS NOTED THAT THE DEVICE WAS NOT CLEANED ACCORDING TO THE MANUAL, WHICH CONTRIBUTED TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294761 ↗
• MalfunctionDec 4, 2024Device Alarm System; Loose or Intermittent Connection; Failure to Analyze Signal; Device Damaged Prior to Use; Low Readings; Device Alarm System; Loose or Intermittent Connection; Failure to Analyze Signal; Device Damaged Prior to Use; Low Readings

  IT WAS REPORTED THAT, INTRA-OPERATIVELY, WHILE PERFORMING THE PROCEDURE AT THE NECK AREA (SENSORS UNDER DRAPING), A LOSS OF SIGNAL WAS RECORDED FOR APPROXIMATELY 2 MINUTES. ONCE THE NIRS SIGNAL REAPPEARED, A -32% DECREASE FROM BASELINE WAS OBSERVED IN THE RIGHT HEMISPHERE, WITH NO LOSS OF SIGNAL QUALITY. TO TRY TO CORRECT THIS PROBLEM, THE DOCTOR GAVE EPHEDRINE TO INCREASE MEAN ARTERIAL PRESSURE (MAP). ALTHOUGH, THE LEFT HEMISPHERE REACTED ADEQUATELY, THE RIGHT HEMISPHERE SHOWED NO IMPROVEMENT. AT THE END OF THE PROCEDURE, THE ANESTHETIST WAS ASKED TO CHECK THE POSITIONING OF THE ELECTRODES. THE RIGHT HEMISPHERE ELECTRODE WAS FOUND TO BE PEELED OFF. THIS HAD CAUSED DISTURBANCE OF THE CURVES DESPITE A SIGNAL QUALITY DEEMED SATISFACTORY BY THE DEVICE. AS THE SENSORS WERE PLACED UNDER STERILE FIELD, THIS SITUATION WAS INVISIBLE DURING THE PROCEDURE. AFTER HAVING REPOSITIONED THE ELECTRODE, THE NIRS OF THE RIGHT HEMISPHERE AT THE END OF THE PROCEDURE RETURNED TO A VALUE OF 70, CONFIRMING THE RETURN TO NORMAL. THE BASELINE WAS SET TO LB 65. IT WAS MENTIONED THAT THERE WAS NO LOSS OF IQS SIGNAL QUALITY INDEX. NO PATIENT COMPLICATION REPORTED. ADDITIONAL INFORMATION HAS BEEN PROVIDED BY T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20841676 ↗
• MalfunctionNov 18, 2024Device Alarm System; Erratic or Intermittent Display; High Readings; Low Readings; Device Alarm System; Erratic or Intermittent Display; High Readings; Low Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20716750 ↗
• MalfunctionNov 18, 2024Device Alarm System; Erratic or Intermittent Display; High Readings; Low Readings; Device Alarm System; Erratic or Intermittent Display; High Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD ERRATIC SPO2 READINGS RANGING FROM ZERO TO HIGH VALUES OF 70, 80, AND 90. FURTHERMORE, THE VALUE DISAPPEARED AND THE MONITOR WAS SHOWING AN ALARM OF 'LOW SOUND LEVEL.' THE MONITORS WERE ALSO CONNECTED THROUGH A MODULE TO A MONITOR BY A DIFFERENT MANUFACTURER. ONE CHANNEL ON THE MONITOR WAS SHOWING A FIXED VALUE OF 62, WHILE THE VALUE ON THE OTHER MONITOR WAS CHANGING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705270 ↗
• MalfunctionNov 18, 2024Device Alarm System; Erratic or Intermittent Display; High Readings; Low Readings; Device Alarm System; Erratic or Intermittent Display; High Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD ERRATIC SPO2 READINGS RANGING FROM ZERO TO HIGH VALUES OF 70, 80, AND 90. FURTHERMORE, THE VALUE DISAPPEARED AND THE MONITOR WAS SHOWING AN ALARM OF 'LOW SOUND LEVEL'. THE MONITORS WERE ALSO CONNECTED THROUGH A MODULE TO A MONITOR BY A DIFFERENT MANUFACTURER. ONE CHANNEL ON THE MONITOR WAS SHOWING A FIXED VALUE OF 62, WHILE THE VALUE ON THE OTHER MONITOR WAS CHANGING. IN ADDITION STRANGE READINGS DEFINED AS CORRUPTED, CABLES AND PRE-AMPLIFIERS WERE USED ALONG WITH THE MONITOR AND VISUAL ALARM SHOWED IN YELLOW. THERE WAS NO SOUND/NO SIGNAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705262 ↗
• MalfunctionNov 6, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING SERVICING, THE PRODUCT GAVE HIGH RSO2 READINGS. 32 PRE-FILED TEST DEVICES WERE SET UP ON 15. THE ERROR OCCURRED DURING THE PDI (PRE-DELIVERY INSPECTION) FROM THE MED TECH DEPARTMENT BEFORE DELIVERY TO THE FINAL DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623902 ↗
• MalfunctionSep 25, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE WAS PRODUCING LOW READINGS IN YELLOW DURING THE PROCEDURE ON A PATIENT. THE SENSOR CABLES WERE SWAPPED, WHICH INDICATED THAT IT WAS A DEVICE ISSUE AND NOT A SENSOR ISSUE. THE DEVICE HAD AUDIBLE AND VISUAL ALARMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301473 ↗
• MalfunctionAug 5, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD LOW READINGS. THE PLACEMENT OF THE SENSORS WERE CONFIRMED. NO FAILURE OR ERROR CODE WAS BEING REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905119 ↗
• MalfunctionAug 5, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE MONITOR HAD LOW READINGS. THE CLINICAL STAFF CONFIRMED THE PLACEMENT OF THE SENSOR AS TROUBLESHOOTING STEP AND VERIFIED THE READINGS WERE BEING READ CORRECTLY AND THERE WAS NO ERROR CODE REPORTED. THE SOFTWARE VERSION WERE UP TO DATE AND PREAMP WAS MATCHED. AN ADULT SENSOR WAS USED IN CEREBRAL LOCATION AND THE CUSTOMER STATED THE SITE WAS HAVING DIFFICULTY GETTING USED TO READINGS THAT HAVE A MORE RELATIVE SPAN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905097 ↗
• MalfunctionAug 5, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE MONITOR HAD LOW READINGS. THE NURSING STAFF CONFIRMED PLACEMENT OF THE SENSORS AND THE READINGS/VALUES BEING READ CORRECTLY. NO FAILURE OR ERROR CODE WAS BEING REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905090 ↗
• MalfunctionAug 5, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE MONITOR HAD LOW READINGS. THE NURSING STAFF CONFIRMED PLACEMENT OF THE SENSORS AND THE READINGS/VALUES BEING READ CORRECTLY. NO FAILURE OR ERROR CODE WAS BEING REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905081 ↗
• MalfunctionJun 4, 2024Failure to Analyze Signal; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD NO RSO2 READING AND DROPPED OUT AFTER ROUGHLY 10 SECONDS. THE PATIENT'S PROCEDURE WAS DELAYED BY ROUGHLY 10 MINUTES, AND THE PATIENT HAD A BCP SURGERY WITHOUT CEREBRAL OXIMETRY MONITORING. THE SENSORS AND THE CABLES WERE CHANGED. ALL EFFORTS WERE MADE TO ENSURE A SIGNAL, BUT THE MONITOR WOULD NOT GIVE A READING. THE MONITOR WAS REMOVED FROM THEATERS AND ATTEMPTED TO GET AN RSO2 READING ON THE USER ITSELF, BUT THE MONITOR WOULD NOT GIVE A READING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463377 ↗
• MalfunctionApr 15, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19109406 ↗
• MalfunctionApr 15, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  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. IT WAS REPORTED THAT THE PROCEDURE WAS NOT CONDUCTED BECAUSE RSO2 WERE NOT RELIABLE. THE DELAY IN PROCEDURE DID NOT CAUSE HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19109130 ↗
• MalfunctionJan 17, 2024Incorrect Measurement; Incorrect Measurement

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

  Patient problems: Insufficient Information

  MAUDE report 18531758 ↗
• InjuryJan 4, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE UNIT HAD THE CEREBRAL AND SOMATIC CHANNELS WERE FLIPPING. WHEN THE MONITOR WAS DISCONNECTED AND THEN RECONNECTED A FEW TIMES, THE SOMATIC THEN SWITCHES TO THE LEFT SIDE OF THE PREAMP AND CEREBRAL LIGHTS UP ON THE RIGHT SIDE. NURSE DID NOT EXPECT THAT THE HOOKUPS TO CHANGE- SO ERRORS IN VALUES WERE HAPPENING. THEN ALSO WHEN DISCONNECTING THE CEREBRAL CHANNEL ¿ THE SOMATIC CAN JUMP TO THE CEREBRAL CHANNEL ¿ THUS MISLABELED AND INCORRECT. THE ISSUE WAS ISOLATED TO THE MONITOR ANG TROUBLE SHOOTING WAS DONE. THE TEAM THOUGHT THE SOMATIC HAD DROPPED BY 15-20%. INCREASE VASODILATION GIVEN ¿ FLUIDS GIVEN.

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

  MAUDE report 18445379 ↗
• InjuryJan 4, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE UNIT HAD THE CEREBRAL AND SOMATIC CHANNELS WERE FLIPPING. WHEN THE MONITOR WAS DISCONNECTED AND THEN RECONNECTED A FEW TIMES, THE SOMATIC THEN SWITCHES TO THE LEFT SIDE OF THE PREAMP AND CEREBRAL LIGHTS UP ON THE RIGHT SIDE. NURSE DID NOT EXPECT THAT THE HOOKUPS TO CHANGE- SO ERRORS IN VALUES WERE HAPPENING. THEN ALSO WHEN DISCONNECTING THE CEREBRAL CHANNEL ¿ THE SOMATIC CAN JUMP TO THE CEREBRAL CHANNEL ¿ THUS MISLABELED AND INCORRECT. THE ISSUE WAS ISOLATED TO THE MONITOR ANG TROUBLE SHOOTING WAS DONE. THE TEAM THOUGHT THE SOMATIC HAD DROPPED BY 15-20%. INCREASE VASODILATION GIVEN ¿ FLUIDS GIVEN.

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

  MAUDE report 18445366 ↗
• MalfunctionOct 19, 2023High Readings; High Readings

  ACCORDING TO THE REPORTER, THE UNIT DISPLAYED FALSELY HIGH VALUES, WHICH WERE CLINICALLY UNEXPLAINABLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17969741 ↗
• MalfunctionOct 19, 2023Erratic or Intermittent Display; Failure to Power Up; Failure to Analyze Signal; High Readings; Erratic or Intermittent Display; Failure to Power Up; Failure to Analyze Signal; High Readings

  ACCORDING TO THE REPORTER, THERE WAS A CONSTANT FAILURE OF THE UNIT VALUES DURING CAUTERIZATION IN CARDIAC SURGERY. THERE WERE CLINICALLY UNEXPLAINABLE FLUCTUATIONS IN THE RSO2 VALUES WITHIN SECONDS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966888 ↗

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