INVOS PM7100 (UDI 10884521780071)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521780071), received between Nov 15, 2021 and Apr 23, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Low Readings” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Erratic or Intermittent Display; Incorrect Measurement; Failure to Analyze Signal; Communication or Transmission Problem; Erratic or Intermittent Display; Incorrect Measurement; Failure to Analyze Signal; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MONITOR WAS INTERMITTENTLY LOSING SIGNAL DURING INTRA-OPERATIVE USE. DURING CASES, ONE SIDE OF THE MONITOR WOULD DROP OUT AND THEN RETURN AFTER A COUPLE OF MINUTES, REPEATING THE CYCLE. DESPITE TROUBLESHOOTING STEPS SUCH AS SWAPPING OUT PREAMPS, CABLES, AND SENSORS, THE ISSUE PERSISTED. A FIELD TEST DEVICE WAS USED ON THE MONITOR TO TEST, BUT THE ISSUE COULD NOT BE REPRODUCED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894617 ↗
• MalfunctionMar 31, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE UNIT HAD INCORRECT READINGS. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21734855 ↗
• MalfunctionMar 17, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PRODUCT HAD INCORRECT READINGS. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21617875 ↗
• MalfunctionNov 10, 2024Failure to Power Up; Low Readings; Failure to Power Up; Low Readings

  ACCORDING TO THE REPORTER, DURING TESTING, THE UNIT WAS TURNED OFF BY ITSELF SPORADICALLY, AND THE READINGS WERE ALSO LOWER THAN MIGHT HAVE BEEN. THE SENSORS WAS SWAPPED OUT AND TESTED WITH MULTIPLE KNOWN WORKING SENSORS WITH NO CHANGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649228 ↗
• MalfunctionNov 6, 2024Incorrect Measurement; Failure to Run on Battery; Incorrect Measurement; Failure to Run on Battery

  ACCORDING TO THE REPORTER, DURING SERVICING, IT WAS FOUND THAT THE DEVICE'S CABLE GAVE INCORRECT VALUES. THE BATTERY WAS ALSO TWO YEARS OLD AND NEEDED REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625687 ↗
• MalfunctionAug 6, 2024Failure to Analyze Signal; Communication or Transmission Problem; Failure to Analyze Signal; Communication or Transmission Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE UNIT HAD A CHECK SENSOR ERROR AND WAS UNABLE TO GET READINGS ON RENAL SITE. PREAMP WAS REPLACED TWICE, THE MONITOR WAS REPLACED, AND THE SENSORS WERE REPLACED THRICE. THE CEREBRAL SITE WORKED WITH NO ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917263 ↗
• MalfunctionAug 6, 2024Failure to Analyze Signal; Communication or Transmission Problem; Failure to Analyze Signal; Communication or Transmission Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE UNIT HAD A CHECK SENSOR ERROR AND WAS UNABLE TO GET READINGS ON RENAL SITE. PRE-AMP WAS REPLACED TWICE, THE MONITOR WAS REPLACED, AND THE SENSORS WERE REPLACED THRICE. THE CEREBRAL SITE WORKED WITH NO ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917261 ↗
• MalfunctionJul 18, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Erratic or Intermittent Display; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, PRIOR TO USE, PRODUCT¿S READING WENT HAYWIRE AND GAVE INCONSISTENT READINGS. THE READINGS OBTAINED WERE BETWEEN 15-40 AND THE NUMBERS WERE FLUCTUATING EVERY MILLISECOND. AUTO BASELINE WAS SET THEN THE NUMBERS KEPT DROPPING AND FLUCTUATING AS THE ABOVE VALUE. AN ATTEMPT TO RESET THE BASELINE WAS MADE, BUT THE NUMBERS WERE STILL FLUCTUATING. SOMETIMES READINGS WAS ALSO LOST. THE SENSOR WAS COVERED WITH THE WHITE TAPE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19774133 ↗
• MalfunctionJan 31, 2024Use of Device Problem; Low Readings; Data Problem; Use of Device Problem; Low Readings; Data Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS PRODUCING LOW READINGS. BOTH THE LEFT AND RIGHT WERE AT 15, IT WAS USED WITH MULTIPLE ADULT SENSORS FOR THREE DAYS WITH 3 DIFFERENT PATIENTS. THE DEVICE COULD NOT ALSO SCROLL BACK IN TIME WHEN LOOKING AT CASE HISTORY. THE UNIT WAS POWER CYCLED, SWAPPED THE PRE AMPS AND THE CASES FOR PATIENTS WERE MISSING. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18619700 ↗
• MalfunctionJan 31, 2024Use of Device Problem; Low Readings; Data Problem; Use of Device Problem; Low Readings; Data Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS PRODUCING LOW READINGS. BOTH THE LEFT AND RIGHT WERE AT 15, IT WAS USED WITH MULTIPLE ADULT SENSORS FOR THREE DAYS WITH THREE DIFFERENT PATIENTS. THE DEVICE COULD NOT ALSO SCROLL BACK IN TIME WHEN LOOKING AT CASE HISTORY. THE UNIT WAS POWER CYCLED, SWAPPED THE PRE AMPS AND THE CASES FOR PATIENTS WERE MISSING. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18619641 ↗
• MalfunctionJan 31, 2024Use of Device Problem; Low Readings; Data Problem; Use of Device Problem; Low Readings; Data Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS PRODUCING LOW READINGS. BOTH THE LEFT AND RIGHT WERE AT 15, IT WAS USED WITH MULTIPLE ADULT SENSORS FOR THREE DAYS WITH 3 DIFFERENT PATIENTS. THE DEVICE COULD NOT ALSO SCROLL BACK IN TIME WHEN LOOKING AT CASE HISTORY. THE UNIT WAS POWER CYCLED, SWAPPED THE PRE AMPS AND THE CASES FOR PATIENTS WERE MISSING. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18616034 ↗
• MalfunctionJan 8, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SALES REP. HAD CUSTOMER THAT WAS ADULT PATIENTS, THE UNIT WAS ONLY REGISTER 15 AND GO NO HIGHER. THE SALES REP. PROVIDED REPLACEMENT CABLES TO CUSTOMER, AND THIS HAD NO AFFECT. THE LOW READING COULD BE PATIENT SPECIFIC DUE TO A DRUG OR THICK SKULL. THERE WAS NO TROUBLESHOOT TAKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18468844 ↗
• 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 NOT-COMPREHENSIBLE, INCORRECTLY 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.

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

  MAUDE report 17921563 ↗
• 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 17921450 ↗
• MalfunctionJun 5, 2023Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW AND UNRELIABLE READINGS. THE VALUE WAS 46 BUT THE OTHER MONITOR WAS 85. THE SENSORS WERE PLACED ON A BREAST FLAP FROM A PATIENT WITH MASTECTOMY AND SUBSEQUENT RECONSTRUCTION AFTER THE SURGERY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17064392 ↗
• MalfunctionJun 3, 2022Device Alarm System; Mechanical Problem; Device Alarm System; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING THE OPERATION OF THE DEVICE MONITOR, IT SWITCHED OFF WITHOUT AN ALARM AND COULD NOT BE RESTARTED. AN EXCHANGE WAS CARRIED OUT. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14593695 ↗
• MalfunctionJan 26, 2022Failure to Analyze Signal; Low Readings; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW READINGS. THE NUMBERS DROPPED OFF THE MONITOR WHEN THE BOVIE WAS TURNED ON. AND THE NUMBERS CAME BACK UP AFTER ABOUT 20 SECONDS. UNIT WAS SWAPPED WITH WORKING PRE-AMP, CABLE, SENSOR. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13357787 ↗
• MalfunctionNov 15, 2021Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS OVERHEATING. THERE WAS NO ALLEGATION OF PATIENT DEATH OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12810730 ↗

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