INVOS PMSENS71-A (UDI 10884521780118)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521780118), received between Oct 28, 2021 and Nov 6, 2024 — classified as 8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, WHILE CARDIOPULMONARY RESUSCITATION WAS ONGOING, THE MONITOR BOOTED AND, MEANWHILE, APPLIED THE SENSOR TO THE FOREHEAD OF THE PATIENT. AFTER BEING ABLE TO SEE THE READINGS ON THE MONITOR, THE HCP'S WONDERED WHY THE READING WAS SO LOW (15% RSO2). IMMEDIATELY USED ANOTHER MONITOR, WHICH SHOWED A READING OF 48%, WHEREAS THE OTHER MONITOR STILL SHOWED 15%. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622316 ↗
• MalfunctionOct 2, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THERE WAS SENSOR NUMERICAL VALUE ERROR. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20354927 ↗
• MalfunctionOct 2, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THERE WAS SENSOR NUMERICAL VALUE ERROR. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20354908 ↗
• MalfunctionJul 10, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD A LOW RSO2 READING. A NEW PRODUCT WAS USED AND TESTED, AND COMPARED TO ITS VALUES, THE REPORTED UNIT HAD VERY LOW VALUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711531 ↗
• MalfunctionJul 10, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD A LOW RSO2 READING. A NEW PRODUCT WAS USED AND TESTED, AND COMPARED TO ITS VALUES, THE REPORTED UNIT HAD VERY LOW VALUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711351 ↗
• MalfunctionApr 29, 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 19199374 ↗
• MalfunctionOct 31, 2021Image Display Error/Artifact; Low Readings; Image Display Error/Artifact; Low Readings

  ACCORDING TO THE REPORTER, ONE SENSOR HAD LOW RSO2 READINGS, WHILE THE OTHER ONE HAD NO READINGS AT ALL. DISPLAYED ERROR MESSAGE "REPLACE SENSORS". BOTH SENSORS WERE REPLACED WITH SAME BATCH SENSORS AND ISSUE WAS RESOLVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725556 ↗
• MalfunctionOct 28, 2021Image Display Error/Artifact; Failure to Analyze Signal; Low Readings; Image Display Error/Artifact; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, ONE SENSOR HAD LOW RSO2 READINGS, WHILE THE OTHER ONE HAD NO READINGS AT ALL. DISPLAYED ERROR MESSAGE "REPLACE SENSORS". BOTH SENSORS WERE REPLACED WITH SAME BATCH SENSORS AND ISSUE WAS RESOLVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712170 ↗

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