Nellcor MAXN-NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884522041638), received between Aug 17, 2018 and Nov 5, 2024 — classified as 1 injury, 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K012891); 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.

• MalfunctionNov 5, 2024Erratic or Intermittent Display; Low Readings; Erratic or Intermittent Display; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT PULSE RATE WAS NORMALLY 120 AND WOULD JUMP SIGNIFICANTLY HIGHER AND INTERMITTENTLY TO AS HIGH AS 225 THAT RESULTS IN TACKY ALARM. THE SPO2 VALUE WAS ALSO SEEN TO DROP INTERMITTENTLY TO LOWER VALUES, AS LOW AS 50 FROM ITS NORMAL VALUE OF 97. CHANGING THE CABLES, SENSORS AND THE MONITORS DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611939 ↗
• MalfunctionDec 1, 2020High Readings; High Readings

  ACCORDING TO THE REPORTER, THE DEVICE WAS NOT READING CORRECTLY WHEN HOOKED UP TO THE PATIENT. IT WAS STATED THAT THE READING WAS HIGHER THAN THE ACTUAL READING WHEN A RUBBER PIECE WAS ADDED OR REMOVED. THERE WAS NO ANY ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10927245 ↗
• InjuryAug 17, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE A CAUSED A BURN ON THE INFANT. THE CUSTOMER REPORTED THAT THE DEVICE WAS USED FOR ABOUT 36 HOURS ON THE INFANT¿S FOOT.

  Patient problems: Injury

  MAUDE report 7793495 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012891. One submission often covers many models, so check the product and lot details in each record.

• Z-0664-05 · Oct 18, 2004 · Terminated
  Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.