INVOS PMPAMP71 (UDI 10884521552616)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521552616), received between Mar 14, 2019 and Jun 20, 2023 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Erratic or Intermittent Display; Low Readings; Erratic or Intermittent Display; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD LOW AND UNRELIABLE READINGS. IN ADDITION THE VALUES WERE HIGHER THAN 80 AND LOW VALUES BELOW 50 ON BOTH SIDE AT THE SOMATIC LEVEL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17160993 ↗
• 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 10350974 ↗
• InjuryNov 20, 2019Incorrect Measurement; Incorrect Measurement

  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 9350951 ↗
• 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 Consequences Or Impact To Patient

  MAUDE report 8616921 ↗
• 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 8527782 ↗
• MalfunctionMar 28, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW RSO2 READING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8462316 ↗
• 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. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.

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

  MAUDE report 8422609 ↗

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