Nellcor MAXNJRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 20884522041710), received between Aug 17, 2017 and Mar 20, 2026 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (13 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Loss of or Failure to Bond; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING USE, THE READING SITE WAS CHANGED REGULARLY EVERY 8 HOURS, YET A BLISTER APPEARED ON THE BIG TOE OF THE LEFT FOOT. DUE TO ISSUES WITH ADHESION STRENGTH, MEDICAL TAPE WAS USED TO ENSURE THAT THE DEVICE DID NOT DETACH.

  Patient problems: Blister

  MAUDE report 24651242 ↗
• MalfunctionSep 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, DURING USE, THE SENSOR WAS ATTACHED TO THE INFANT'S RIGHT WRIST USING AN INFANT WARMER AFTER BIRTH. APPROXIMATELY ONE HOUR LATER, WHEN THE DEVICE WAS MOVED TO THE LEFT WRIST, REDNESS WAS OBSERVED ON THE RIGHT WRIST. A DERMATOLOGIST DIAGNOSED THE CONDITION AS A LOW-TEMPERATURE BURN.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23161859 ↗
• MalfunctionSep 16, 2025Failure to Analyze Signal; Low Readings; Failure to Analyze Signal; Low Readings

  IT WAS REPORTED THAT DURING USE, THE DEVICE HAD ABNORMAL READING VALUE. AT THE BEGINNING, A LOW READING CAME OUT, AND THEN READING DISAPPEARED. SENSOR WAS PLACED ON THE INDEX FINGER AND WAS SECURED USING AN ASSISTIVE TAPE AND THE SENSOR WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067173 ↗
• MalfunctionAug 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE DEVICE SENSOR WAS APPLIED FOR A LONG TIME AND A BURN OCCURRED. THE RECOMMENDED 8 HOURS WERE WRITTEN IN THE MANUFACTURER'S REFERENCE MATERIAL, BUT THE HOSPITAL HAS GIVEN A FULL 2 DAYS. AS A RESULT, THE PATIENT SUFFERED FROM BURNS.

  Patient problems: Burn(s)

  MAUDE report 22708227 ↗
• MalfunctionJul 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING USE, IT WAS SUSPECTED THAT COMPRESSION AND THE LIGHT-EMITTING PART OF THE SENSOR CAUSED SKIN DAMAGE ON THE SOLE OF THE PATIENT'S FOOT. THE SENSOR WAS USED FOR 24 HOURS OR MORE PRIOR TO THE SKIN DAMAGE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 22374319 ↗
• MalfunctionJun 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING USE, IT WAS SUSPECTED THAT COMPRESSION AND THE LIGHT-EMITTING PART OF THE SENSOR CAUSED SKIN DAMAGE ON THE SOLE OF THE PATIENT'S FOOT. THE SENSOR WAS USED FOR 24 HOURS OR MORE PRIOR TO THE SKIN DAMAGE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 22122134 ↗
• MalfunctionMar 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING USE, THE SENSOR WAS PROPERLY FITTED TO THE PATIENT BUT HAD SKIN PROBLEMS AND BEDSORES ON THE HANDS AND FINGERS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21631743 ↗
• MalfunctionSep 30, 2024Failure to Analyze Signal; Manufacturing, Packaging or Shipping Problem; Failure to Analyze Signal; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, A NEW PRODUCT WAS OPENED AND USED, BUT THERE WERE MANY VALUES. AFTER REPLACING IT WITH ANOTHER, READING WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338407 ↗
• MalfunctionJun 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, A RED INFLAMMATION-LIKE SUBSTANCE WAS OBSERVED ON THE DORSUM OF THE FOOT, WHERE THE SENSOR WAS APPLIED. THE PATIENT'S FAMILY REPORTED THAT THE PRODUCT WAS REMOVED WITHIN EIGHT HOURS AND CONFIRMED THAT THERE WAS NO MAJOR DIFFERENCE FROM THE INSTRUCTIONS ON THE PACKAGE REGARDING THE POSITION OF APPLICATION. IT WAS SUSPECTED FOR BURN AND BEDSORE, BUT THE PATIENT HAD NO MEDICAL CONSULTATION BY THE ATTENDING PHYSICIAN, SO THERE WAS NO MEDICAL PRESCRIPTION AT THIS TIME. AFTER A MEDICAL PROFESSIONAL WAS CONSULTED AND THE POSITION OF APPLICATION FROM THE INSTEP TO THE THUMB WAS CHANGED, THERE WERE NO PROBLEMS. THE PRODUCT WAS CONTINUED TO USE WHILE MONITORING THE PATIENT'S CONDITION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19521022 ↗
• MalfunctionFeb 2, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635724 ↗
• MalfunctionSep 12, 2023Failure to Read Input Signal; Low Readings; Failure to Read Input Signal; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, WHILE ON A PATIENT WHOM THIS SENSOR WAS ATTACHED, AN SPO2 VALUE DISPLAY OF 20% APPEARED. WHEN IT WAS REPLACED WITH A NEW SENSOR, 97% WAS DISPLAYED. DUE TO A POSSIBLE SENSOR DEFECT, THE SENSOR WAS COLLECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731073 ↗
• MalfunctionJun 30, 2023Device Damaged Prior to Use; Defective Device; Patient Device Interaction Problem; Device Damaged Prior to Use; Defective Device; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT'S CABLE GOT EXPOSED WITHIN 24 HOURS OF BEING IN USE. IT WAS NOTED THAT THERE WAS A LACK OF DURABILITY IN THE REPORTED PRODUCT. THE PATIENT HAD A RED DOT MARK.

  Patient problems: Inflammation

  MAUDE report 17238333 ↗
• MalfunctionMay 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, AFTER APPROXIMATELY 10 MINUTES, WHEN THE SITE WAS CHECKED, BLISTERS AND RUBBING OF THE SKIN WERE OBSERVED WHERE THE SENSOR WAS ATTACHED (RIGHT WRIST). THERE WAS A POSSIBILITY OF LOW-TEMPERATURE BURNS AND THE TAPE OF THE SENSOR TRAINING PART HAD PEELED OFF.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17004517 ↗
• MalfunctionMay 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CAUSED A BURN-LIKE BLISTER ON THE PATIENT'S BIG TOE (BOTH RIGHT AND LEFT) OF THE FEET THREE DAYS AFTER THE START OF USE. IT WAS VISIBLE AFTER THE REMOVAL OF THE SENSOR.

  Patient problems: Blister

  MAUDE report 16921856 ↗
• MalfunctionJun 24, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE COATING AT THE CONNECTION PART OF THE SENSOR AND THE CABLE WAS FOUND TO BE PEELING OFF. THERE WAS A BURN OR DECUBITUS-LIKE SKIN TROUBLE NEAR THE ABDOMEN OF THE PINKY TOE OF THE RIGHT FOOT. THERE WAS A TENDENCY OF RECOVERY AND HAS ALREADY BEEN DISCHARGED.

  Patient problems: Burn(s)

  MAUDE report 14806466 ↗
• MalfunctionDec 3, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED BURNS, DEVICE WAS USED TO A NEWBORN PATIENT. THE SENSOR MOUNTING PART WAS REPLACED EVERY 3 HOURS AND SENSOR WAS ON THE 5TH DAY OF USE. THE PATIENT WAS DISCHARGED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12925626 ↗
• MalfunctionDec 21, 2020High Readings; High Readings

  ACCORDING TO THE REPORTER, IMMEDIATELY AFTER STARTING TO USE THE UNIT, PR WAS DISPLAYED AT OVER 200. WHEN REPLACED WITH A NEW SENSOR, IT DISPLAYED NORMALLY. SEPARATELY, WHEN THE STAFF CHECKED IT AGAIN ON AN ADULT, IT WAS DISPLAYED NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047306 ↗
• MalfunctionDec 18, 2020High Readings; High Readings

  ACCORDING TO THE REPORTER, THE PRODUCT DISPLAYED THE PATIENT¿S PULSE RATE AT OVER 200. WHEN REPLACED WITH A NEW SENSOR, NORMAL READING OF 120-130 WAS DISPLAYED. SEPARATELY, WHEN THE SAME PRODUCT WAS CHECKED WITH ANOTHER ADULT, NORMAL READING WAS DISPLAYED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11036512 ↗
• MalfunctionOct 2, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE ON A (B)(6), THE PRODUCT WAS PROVIDING READINGS BY USING IT ON THE BIG TOE, BUT PRESSURE ULCER OCCURRED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 10623928 ↗
• MalfunctionJul 20, 2020Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE SENSOR GOT HOT. WHEN AN INCISION WAS MADE WITH AN ELECTRIC SCALPEL, THE STIMULUS RAN ON THE FINGERTIP. SINCE THE ELECTRIC SCALPEL WAS BIPOLAR, THE RETURN ELECTRODE WAS NOT ATTACHED, BUT EVEN WITH A RETURN ELECTRODE, THE STIMULUS STILL RAN WHEN THE INCISION WAS MADE. WHEN THE OPERATION DEPARTMENT CHIEF TOUCHED THE SENSOR WHILE HOLDING THE PATIENT'S HAND, HE/SHE FELT THAT IT WAS "HOT." WHEN THE SENSOR WAS REPLACED WITH A NEW ONE, IT WAS ABLE TO BE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10294409 ↗
• InjuryAug 12, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, DURING USE OF THE DEVICE, SKIN TROUBLE WAS NOTED ABOUT 5MM RED RASH. THE PATIENT WAS RECOVERED AND STILL UNDER OBSERVATION.

  Patient problems: Rash

  MAUDE report 8882116 ↗
• MalfunctionApr 15, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CABLE BASE PART WAS BROKEN. IT WAS REPORTED THAT THE PATIENT HAD REDDENING OR THERMAL BURN.

  Patient problems: Burn, Thermal

  MAUDE report 8515142 ↗
• InjuryFeb 22, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A LESS THAN 1MM SQUARE BLISTER AT THE LEFT SECOND FINGER. THE BLISTER WAS MILD AND TURNED INTO RED THE NEXT DAY.

  Patient problems: Injury

  MAUDE report 8362123 ↗
• MalfunctionAug 30, 2017Low Readings; No Apparent Adverse Event; Low Readings; No Apparent Adverse Event

  DURING USE, A PATIENT'S SPO2 VALUE BECAME 90% ALTHOUGH THE PAO2 VALUE EXCEEDED 200. THE SENSOR WAS REPLACED THEN IT SHOWED NORMAL VALUE. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6831383 ↗
• MalfunctionAug 17, 2017Low Readings; Low Readings

  MEDTRONIC RECEIVED A REPORT WHERE IT WAS ALLEGED THAT THE UNIT PROVIDED A READING THAT WAS LOWER THAN THE EXPECTED VALUE AND THE PROBLEM WAS ISOLATED TO THE REPORTED SENSOR. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6802773 ↗

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.