Nellcor 10005063Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30884521080557), received between Jun 15, 2021 and Jun 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 12000213 ↗

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