Nellcor RS10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884522042529), received between Jun 15, 2021 and May 19, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K904039); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A PRESSURE INJURY OR SMALL BURN WITH A LINEAR ABRASION ON A PATIENT ON A PRESSOR WITH POOR PERFUSION WHERE THE HEADBAND WAS TOO TIGHT. THE PATIENT'S HEAD CIRCUMFERENCE WAS 24 INCHES. THE SKIN INTEGRITY ISSUE WAS VISIBLE IMMEDIATELY AFTER THE REMOVAL OF THE SENSOR. IT STAYED IN PLACE FOR FOUR HOURS AT THE SITE OF THE SKIN INTEGRITY ISSUE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16964429 ↗
• MalfunctionMar 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE PATIENT RECEIVED BURNS WHILE USING SENSOR.

  Patient problems: Burn(s)

  MAUDE report 16568614 ↗
• InjuryMar 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS BURNED WHILE USING THE SENSOR.

  Patient problems: Burn(s)

  MAUDE report 16564508 ↗
• MalfunctionJun 15, 2021Human-Device Interface Problem; Patient Device Interaction Problem; Human-Device Interface Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, IT WAS NOTED THAT THE SITE DID NOT CHECK THE SENSOR EVERY AMOUNT OF HOURS TO CONFIRM THAT THE DEVICE WAS NOT LEAVING PRESSURE ON THE PATIENT. IN ADDITION THEY DID NOT MOVE THE SENSOR AS WELL AND NOTED THAT INSTEAD OF A BURN IT WAS CONSIDERED A PRESSURE WOUND SINCE THERE WAS NO HEAT NOTED TO CAME FROM THE SENSOR. THE PATIENT EXPERIENCED PRESSURE INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12005838 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K904039. One submission often covers many models, so check the product and lot details in each record.

• Z-1125-2017 · Dec 16, 2016 · Terminated
  Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen satu