Nellcor MAXNRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 20884522041727), received between Feb 27, 2018 and Apr 13, 2026 — classified as 1 death, 5 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (14 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Low Readings

  IT WAS REPORTED THAT DURING USE, THE OXYGEN SATURATION HAD AN INACCURATE MEASUREMENT. THE OPERATOR FOLLOWED INSTRUCTIONS, USING AN UNOPENED DEVICE WITHIN ITS EXPIRATION DATE, AND CONNECTED THE PULSE OXIMETER SENSOR TO THE PATIENT MONITOR. AFTER 10 HOURS, THE OXYGEN SATURATION WAVEFORM ON THE MONITOR APPEARED NORMAL, BUT THE DISPLAYED VALUE WAS 79%. THE MONITORING RESULT WAS SERIOUSLY INCONSISTENT WITH THE PATIENT¿S ACTUAL CONDITION, LEADING TO ABNORMAL MONITORING AND POSING A SIGNIFICANT SAFETY RISK. AFTER DISCOVERING THE ISSUE AND REPORTING IT TO THE PHYSICIAN, BEDSIDE BLOOD GAS ANALYSIS WAS IMMEDIATELY PERFORMED AND PREPARATIONS FOR ENDOTRACHEAL INTUBATION WERE MADE. THE BEDSIDE BLOOD GAS ANALYSIS SHOWED AN OXYGEN SATURATION OF 99%. A NEW PULSE OXIMETER SENSOR WAS THEN USED TO RE-MONITOR THE PATIENT¿S OXYGEN SATURATION. AFTER REPLACING THE PULSE OXIMETER SENSOR, NO ABNORMALITIES WERE OBSERVED DURING MONITORING, AND THE PATIENT¿S CONDITION STABILIZED AFTER MONITORING WAS RESTORED.

  Patient problems: Chest Pain

  MAUDE report 24858063 ↗
• InjuryMar 30, 2026Device Alarm System; Incorrect Measurement; Failure to Analyze Signal; Low Readings

  IT WAS REPORTED THAT OXYGEN SATURATION WAS INACCURATE DURING USE. THE OPERATOR FOLLOWED INSTRUCTIONS, USING AN UNOPENED DEVICE WITHIN ITS EXPIRATION DATE, AND CONNECTED THE PULSE OXIMETER SENSOR TO THE PATIENT FINGER SECURED WITH SELF-ADHESIVE TYPE TAPE. AFTER 20 HOURS, THE NURSE FOUND THE PATIENT UNCONSCIOUS, AND ADJUSTING THE SENSOR DID NOT YIELD READINGS. MONITORING RESULTS WERE INCONSISTENT, POSING A SIGNIFICANT SAFETY HAZARD. THE NURSE INITIATED RESCUE, PERFORMED A BEDSIDE OXYGEN SATURATION CHECK, AND PROVIDED PRESSURIZED OXYGEN VIA MASK. THE REPORTED SPO2 READING WAS 75%, WHEREAS THE BLOOD GAS RESULTS SHOWED 96% SATURATION. AFTER REPLACING THE PULSE OXIMETER SENSOR, MONITORING RETURNED TO NORMAL AND THE PATIENT¿S CONDITION STABILIZED. THERE WAS NO AUDIBLE AND VISUAL ALARMS TRIGGERED.

  Patient problems: Loss of consciousness

  MAUDE report 24719989 ↗
• MalfunctionJan 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT BLISTERING OCCURRED FROM THE USE OF THE SENSOR. THE ISSUE WAS OBSERVED IN 12-MONTH-OLD FEMALE BABY AND WAS UNCLEAR WHETHER THE BLISTERS WERE ASSOCIATED WITH THE ADHESIVE OR THE SENSOR LIGHT AREA.

  Patient problems: Blister

  MAUDE report 21206956 ↗
• MalfunctionJan 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT BLISTERING OCCURRED FROM THE USE OF THE SENSOR. THE ISSUE WAS OBSERVED IN 12-MONTH-OLD FEMALE BABY AND WAS UNCLEAR WHETHER THE BLISTERS WERE ASSOCIATED WITH THE ADHESIVE OR THE SENSOR LIGHT AREA.

  Patient problems: Blister

  MAUDE report 21200808 ↗
• MalfunctionAug 21, 2024High Readings; Low Readings; High Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT DISPLAYED READINGS OF 70 SPO2 AND 200 BPM. THE CUSTOMER CALLED THE EMERGENCY HOTLINE FOR A POTENTIAL CARDIAC ARREST BECAUSE THE READINGS ON THE OXIMETER WERE ALARMINGLY LOW. WHEN THE EMTS ARRIVED, THE PATIENT WAS FINE, BUT THE READINGS WERE STILL LOW. THE RESPONDER'S OXIMETER SHOWED SPO2 AT 99% AND A HEART RATE (HR) OF 140, WHILE THE CUSTOMER'S DEVICE SHOWED SPO2 IN THE 70S AND HR IN THE 200S WITH MULTIPLE PROBES, FREQUENTLY DROPPING TO 0 BEFORE RISING AGAIN. SENSORS AND THE UNIT WERE SWAPPED TO ISOLATE THE ISSUE. NO ERROR CODES WERE DISPLAYED. AN ADHESIVE WAS USED TO HOLD THE SENSOR IN PLACE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013668 ↗
• MalfunctionMar 8, 2024Mechanical Problem; Manufacturing, Packaging or Shipping Problem; Mechanical Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SPO2 WAS REMOVED FROM PACKAGING DURING A PEDIATRIC CARDIAC/RESPIRATORY ARREST (CODE LILY) AND THE ADHESIVE BAND FELL APART. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871145 ↗
• MalfunctionFeb 28, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR WAS NOTED TO BE READING LOWER THAN A DIFFERENT SENSOR AFTER BEING SWAPPED OUT. IT WAS NOTED THAT PATIENT'S FINGER HAD NAIL POLISH. THE CUSTOMER WAS ADVISED TO CHECK FOR PLACEMENT, LIGHT-EMITTING DIODE (LED) LIGHTING, MOVEMENT OF THE PATIENT AND THAT NAIL POLISH SHOULD NOT BE ON PATIENT AS IT COULD CAUSE INACCURATE READINGS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18802434 ↗
• InjuryFeb 5, 2024

  SPO2 SENSOR WAS REMOVED FROM PACKAGING DURING CODE LILY AND THE ADHESIVE BAND FELL APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650325 ↗
• MalfunctionFeb 2, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD NO ACCURATE SENSOR READING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636845 ↗
• DeathJan 29, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT WAS READING 94% SATURATION FOR HOURS BUT DID NOT LOOK TO BE 94%. THEN SUDDENLY THE PATIENT CODED, WAS INTUBATED AND LATER DIED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18597346 ↗
• MalfunctionDec 5, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE SENSOR CAUSED BURNS ON A PATIENT. THE SENSOR WAS IN PLACE AT THE PATIENT FOR 24 HOURS AND THERE WERE BLISTERS THAT FORM ON THE SENSOR SITE AFTER A DAY OF USE. THE SENSOR SITE WAS CHECKED DAILY AND NOTED THAT THE BLISTERS STARTED TO BE SEEN AFTER THE PATIENT STARTED TO WEAR LOOSE FITTING SOCKS. IT WAS REPORTED THAT THE BLISTERING TOOK ONE WEEK TO HEAL.

  Patient problems: Blister

  MAUDE report 18268089 ↗
• MalfunctionOct 12, 2023Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, A BURNING SMELL WAS NOTICED  IN THE PATIENT'S ROOM BUT NOTHING WAS DISCOVERED. APPROXIMATELY ONE HOUR LATER, THERE WAS AN ELECTRICAL SHORT OF THE SENSOR AND A CHARRED SPO2 SENSOR WAS SEEN ON THE PATIENT'S LEFT INDEX FINGER. THE CABLE SLEEVE MELTED EXTENDED FROM THE ATTACHMENT POINT TO THE PATIENT ONCE INCH BELOW THE ATTACHMENT POINT. THE SENSOR STAYED IN PLACE AT THE SITE OF THE SKIN FOR 24 HOURS. THERE WAS NO SKIN ISSUE ASSESSED BEFORE OR AFTER AND THE PATIENT WAS DISCHARGED TO HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17923945 ↗
• MalfunctionSep 28, 2023Failure to Analyze Signal; Failure to Analyze Signal

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR HAD NO PLETH PICKED UP AT ALL. IT DID NOT WORK ON THE LEFT INDEX FINGER, THE FINGER WAS WARM WITH ADEQUATE BLOOD FLOW. THE SENSOR WAS UNPLUGGED AND PLUGGED BACK IN USING THE CORRECT BLUE CORD TO THE MONITOR. ENDED UP USING A TOE AND RECEIVED A PLETH WITH A READING BUT IT WAS NOT GOOD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840337 ↗
• MalfunctionAug 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, WHEN THE SENSOR WAS PLACED FOR A LESS THAN AN HOUR TO THE PATIENT, A DARK PURPLE AND BLACK IN COLOR AROUND PROBE AREA ON FINGER APPEARED TO BE AN ELECTRICAL BURN. IT WAS NOTICED APPARENT IMMEDIATELY AFTER REMOVAL OF SENSOR. THE PATIENT WAS SITTING AT BEDSIDE IN A RECLINER. THE SITE OF WHERE THE SENSOR APPLIED WAS PERIODICALLY CHECKED. THERE WAS NO ADDITIONAL FORCES ON THE SENSOR. THE WOUND WAS NOT STAGED. THERE WAS NO ANY SKIN PREPARATION PERFORMED PRIOR TO APPLICATION OF THE SENSOR. THERE WAS A MEDICAL CONSULTATION INCLUDING TREATMENTS AND PATIENT OUTCOME.

  Patient problems: Skin Burning Sensation; Skin Discoloration; Unspecified Tissue Injury

  MAUDE report 17502760 ↗
• MalfunctionMay 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE SENSOR WAS PLACED ON THE TOE OF A TODDLER AND A BURN WAS OBSERVED AS OPPOSED TO A PRESSURE INJURY BY PHYSICIAN DIAGNOSIS. THE BURN WAS NOTED ON THE BOTTOM LEFT GREAT TOE WITH NO OPEN SKIN, BUT WITH BLACKENED AREA. A BLUE FOAM POSEY WAS ADDED ON THE SENSOR. THE PATIENT DISCONTINUED THE SENSOR AND SPOT CHECK WAS ORDERED. THE PATIENT DID NOT REQUIRE INTERVENTION AND WAS DISCHARGED AFTER 2.5 DAYS ADMISSION.

  Patient problems: Burn(s)

  MAUDE report 16996043 ↗
• MalfunctionMay 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE SENSOR WAS PLACED ON WRIST OF A NEWBORN PATIENT AND A BURN WAS OBSERVED AS OPPOSED TO A PRESSURE INJURY BY PHYSICIAN DIAGNOSIS. THE DEVICE WAS REPLACED FOR ONGOING MONITORING. THE PATIENT REQUIRED OINTMENT AND GAUZE DRESSING. THE SENSOR STAYED ON THE SITE FOR 8 HOURS AND A BLUE FOAM POSEY WAS ADDED ON THE ON SENSOR.

  Patient problems: Burn(s)

  MAUDE report 16994166 ↗
• InjurySep 15, 2022Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE INFANT HAD INITIAL CCHD (CONGENITAL CARDIAC HEART DEFECT) READING AND RESULTS OF PRE AND POST DUCTAL SATURATIONS WITH SENSOR REQUIRED 4 LIMB BP. THE INFANT WAS BROUGHT TO SCN (SPECIAL CARE NURSERY), PRE AND POST DUCTAL SET READINGS WITH SPO2 SENSOR CONTINUED TO BE DIFFERENT WITH EACH READING REQUIRING THE INITIATION OF OXYGEN. THE PHYSICIAN WAS NOTIFIED AND ORDERS RECEIVED TO START ON O2. THE BABY REQUIRED OXYGEN DELIVERY FOR APPROXIMATELY 5 HOURS BEFORE BEING WEANED AFTER TRYING DIFFERENT VITAL SIGN MONITORS WITH NO CHANGE. WHEN A NEW SPO2 SENSOR WAS USED, THERE WERE NORMAL READINGS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 15428455 ↗
• MalfunctionAug 19, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD PRESSURE WOUND FOUND AT THE SITE OF SENSOR PLACEMENT, NOTICED BY NURSE IN THE NICU. THERE WAS A BURN AND BLISTER SEEN ON THE PATIENT'S FOOT AND IT WAS DEEMED THAT IT WAS FROM THE LIGHT SENSOR. CUSTOMER THOUGHT THAT THE LIGHT  ON THE SENSORS WAS WARM ENOUGH TO BURN THROUGH THEIR UNIT. PATIENT WAS ISOLATED. THE SENSOR STAYED IN PLACE AT THE SITE OF SKIN INTEGRITY ISSUE FOR 3 HOURS, AND WAS ON SUPINE POSITION. THE SKIN INTEGRITY ISSUE WAS VISIBLE IMMEDIATELY AFTER SENSOR WAS REMOVED. THE PATIENT HAD TWO BURN LIKE MARKINGS WHERE THE SENSORS ARE ON THE FOOT. SKIN CHECKED EVERY THREE HOURS ON THREE OTHER SITE AND LASTED FOR ONE WEEK. PLASTIC SURGERY AND WOUND CARE NURSE WERE CONSULTED. SKIN WAS TREATED THROUGH OPEN AIR. THE PATIENT RECOVERED BUT MARKINGS WAS STILL ON THE FOOT. PATIENT WAS PREMATURE, AND HAD NO EXISTING ALLERGIES AND SKIN CONDITIONS.

  Patient problems: Blister; Burn(s)

  MAUDE report 15262869 ↗
• MalfunctionAug 18, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CAUSED PRESSURE WOUND TO THE PATIENT. IT WAS REPORTED THAT THERE WAS A BURN AND BLISTER SEEN ON THE PATIENT'S FOOT.

  Patient problems: Blister; Burn(s)

  MAUDE report 15250540 ↗
• MalfunctionAug 18, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CAUSED PRESSURE WOUND FOUND AT THE SITE OF SENSOR PLACEMENT, NOTICED BY NURSE IN THE NICU. IMMEDIATELY AFTER SENSOR WAS REMOVED, THE PATIENT HAD A BLISTER AND MULTIPLE BURN LIKE MARKING CIRCUMFERENTIAL AROUND THE FOOT. THE SENSOR STAYED IN PLACE AT THE SITE OF SKIN INTEGRITY ISSUE FOR 3 HOURS, SITE ROTATED EVERY THREE HOURS AND WAS ON PRONE POSITION. THE SKIN INTEGRITY ISSUE LASTED FOR 1 WEEK. PLASTIC SURGERY AND WOUND CARE NURSE WERE CONSULTED. THE SKIN TREATED WITH BACITRACIN. THE PATIENT RECOVERED BUT MARKINGS WERE STILL ON THE FOOT. PATIENT WAS PREMATURE, AND HAD NO EXISTING ALLERGIES AND SKIN CONDITIONS.

  Patient problems: Blister; Burn(s)

  MAUDE report 15250539 ↗
• MalfunctionDec 29, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD EXPOSED WIRES. THE PATIENT HAD BURN NOTED ON THE LEFT ANKLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13115799 ↗
• MalfunctionApr 1, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED BURNED BY THE SENSOR. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Burn(s)

  MAUDE report 11602347 ↗
• MalfunctionJan 15, 2021Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE THIRTY THREE WEEKS PREMATURE BABY HAD A BURN TO THE RIGHT FOOT, BOTH AT THE TOP AND THE BOTTOM OF THE FOOT. IT WAS INDICATED THAT THE NURSE CHANGED THE SENSOR'S LOCATION AFTER EIGHT HOURS OF CONTINUOUS USE TO INSPECT THE SKIN AS PER HOSPITAL PROTOCOL. THERE WAS PATIENT INJURY.

  Patient problems: Burn(s); Pressure Sore/Ulcer

  MAUDE report 11176927 ↗
• MalfunctionJan 5, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE THIRTY THREE WEEKS PREMATURE BABY HAD A BURN ON THE RIGHT FOOT, BOTH AT THE TOP AND THE BOTTOM OF THE FOOT. THE NURSE CHANGED THE SENSOR'S LOCATION AFTER EIGHT HOURS OF CONTINUOUS USE TO INSPECT THE SKIN AS PER HOSPITAL'S PROTOCOL. IT WAS INDICATED THAT NO SPECIFIC TREATMENT WAS APPLIED TO THE BURN. THERE WAS PATIENT INJURY.

  Patient problems: Burn(s)

  MAUDE report 11116254 ↗
• MalfunctionJun 9, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, WHILE TAKING OFF THE DEVICE FROM LEFT MIDDLE TOE, A PRESSURE INJURY WAS NOTICED AND CATEGORIZED AS STAGE ONE PRESSURE INJURY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 10132899 ↗

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.