INVOS IS (UDI 10884521211117)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521211117), received between Jun 15, 2020 and Aug 7, 2024 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K091224, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD LOW INTERMITTENT READINGS ON THE NEW SYSTEM USING THE SENSORS ON CARDIAC PEDIATRIC PATIENT AND RENAL SENSING. THE PATIENT WAS ON A PRONE POSITION, AND THE FLANK SENSOR HAD NO DIFFICULTY GETTING A READING. BUT WHEN THE PATIENT WAS PLACED IN SUPINE, THE READINGS WERE BACK TO AN INTERMITTENT READING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928497 ↗
• DeathDec 13, 2023Failure to Analyze Signal; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE WAS UNABLE TO OBTAIN A RENAL RSO2 READING ON A 28 WEEK PREMIE PATIENT. PATIENT DIED, AND THE DEATH WAS ATTRIBUTED TO OVER CIRCULATION. THE PATIENT'S DEATH IS NOT DEVICE RELATED.

  Patient problems: Insufficient Information

  MAUDE report 18323747 ↗
• MalfunctionDec 1, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THERE WAS A WOUND BELOW THE CEREBRAL SENSOR ON A PREMATURE PATIENT. THE PATIENT WAS INJURED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 10924746 ↗
• MalfunctionOct 21, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED AN PRESSURE INJURY TO THE PATIENT. THERE WAS PATIENT INJURY.

  Patient problems: Skin Irritation

  MAUDE report 10713311 ↗
• MalfunctionJun 15, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THERE WAS PRESSURE INJURY ON ONE INFANT WHERE THE FLANK PROBE WAS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 10153555 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091224, 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