INVOS IS (UDI 10884521810365)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521810365), received between Mar 18, 2024 and Apr 12, 2024 — classified as 3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CAUSED A MILD SKIN IRRITATION ON THE RIGHT SIDE OF THE FOREHEAD WHEN THE PATIENT WAS EVALUATED LESS THAN ONE HOUR POST-PROCEDURE IN THE STEP-DOWN UNIT. THE IRRITATION WAS PINK AND OUTLINED WHERE THE SENSOR WAS PLACED FOR AN HOUR. THE PATIENT WAS IN SUPINE POSITION AND SKIN WAS CHECKED PRIOR TO APPLICATION, AFTER REMOVAL AND AT DISCHARGE. IT WAS INDICATED THAT THE PATIENT HAD SENSITIVE SKIN. NO MEDICAL CONSULTATION OR TREATMENT WAS NEEDED.

  Patient problems: Rash

  MAUDE report 19102226 ↗
• MalfunctionMar 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR WAS PLACED ON THE PATIENT'S FOREHEAD AND THE BACK (RENAL) SIDE. A BURN/REDNESS ON THE PATIENT'S FOREHEAD WAS SEEN AFTER REMOVING THE SENSOR. RELEASING OF THE ADHESIVE SENSOR FROM THE SKIN CAUSED A TEAR ALONG THE BURN. IT WAS NOTED THAT THE CUSTOMER HAD A PROTOCOL TO REPLACE THE SENSOR EVERY 48 HOURS. THE HOSPITAL WOUND CARE WAS CONSULTED AND A BARRIER CREAM WAS APPLIED ON THE REDNESS.

  Patient problems: Burn(s)

  MAUDE report 18927290 ↗
• MalfunctionMar 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE SENSOR WAS PLACED ON THE PATIENT'S FOREHEAD AND A BURN ON THE SKIN WAS SEEN IMMEDIATELY AFTER REMOVING THE SENSOR. THE SENSOR STAYED ON THE PATIENT'S SKIN FOR 48 HOURS. THE HOSPITAL WOUND CARE WAS CONSULTED AND A BARRIER CREAM WAS APPLIED ON THE REDNESS.

  Patient problems: Burn(s)

  MAUDE report 18927275 ↗

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