Nellcor 904-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521084107), received between Feb 20, 2019 and Jul 25, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K993637); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2023Incorrect Measurement; Appropriate Device Problem Term/Code Not Available; Incorrect Measurement; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT DESATURATED AT 89% SATURATION: PUT ON 1LO2 AND 1 HOUR LATER, PATIENT AT 93% STILL ON 1LO2 WITH A WELL OSCILLATING AND REGULAR CURVE WITH SENSOR HEART RATE CORRELATED WITH ECG (ELECTROCARDIOGRAM) HEART RATE. PATIENT HAS WELL COLORED NORMAL RESPIRATORY DYNAMICS CHANGE OF SATURATION SENSOR AND THERE WAS 100% SATURATION IN ROOM AIR. THE UNIT HAD WRONG MEASUREMENT OF SPO2.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17390829 ↗
• InjuryFeb 20, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THERE WAS A SKIN RASH ON THE FOOT WHERE THE SATURATION WAS PLACED. IT WAS REPORTED THAT THE POSITION OF THE SENSOR WAS CHANGED. IT WAS REPORTED THAT THERE WAS PAIN AT PALPATION AND PERSISTENCE OF THE ALTERED STATED OF SKIN, WHICH NECESSARY TO APPLY SCAR CREAM.

  Patient problems: Pain; Skin Irritation

  MAUDE report 8354221 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993637. One submission often covers many models, so check the product and lot details in each record.

• Z-0665-05 · Oct 18, 2004 · Terminated
  Nellcor brand Pulse Oximeter, model N-395, Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.