INVOS PMPAMP71 (UDI 10884521810112)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521810112), received between Nov 29, 2022 and Jul 30, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT PRIOR SURGERY, THE PREAMPLIFIER WAS NOT CAPTURING THE DATA CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668841 ↗
• 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 20705240 ↗
• 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 20705192 ↗
• 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 20705181 ↗
• MalfunctionNov 6, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING SERVICING, THE DEVICE WAS CHECKED AND THE PREAMPLIFIER WAS MEASURED. WHEN IT WAS CONNECTED TO THE TESTER, IT DID NOT DISPLAY AS 70.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623778 ↗
• MalfunctionSep 12, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE PRODUCT DID NOT WORK PROPERLY AND SHOWED UNNATURAL MEASUREMENTS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20198819 ↗
• MalfunctionAug 12, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD AN UNSTABLE SYSTEM, DID NOT CAPTURE AND HAD A LARGE DATA VARIATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19962510 ↗
• MalfunctionApr 29, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209833 ↗
• MalfunctionApr 15, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Erratic or Intermittent Display; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, DURING USE,  THE DEVICE HAD AN ERRATIC RSO2 READINGS FROM BELOW 15 TO HIGH 50S OR NO READINGS. IT COULD NOT MONITOR THE PATIENT FROM SURGERY FOR CORONARY ARTERY BYPASS WARM BEATING. THE MONITOR AND PREAMPS AND CABLES WERE SWAPPED BUT SENSOR CONTINUED TO READ ERRATICALLY. THE EVENT RESULT IN A DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106651 ↗
• MalfunctionApr 15, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105427 ↗
• MalfunctionNov 29, 2022Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD LOW READINGS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880266 ↗

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