Nellcor MAXIIRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 20884522041277), received between Sep 25, 2020 and Jan 24, 2025 — classified as 1 death, 5 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Low Readings” (29 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT A LOW SPO2 READING WAS OBSERVED DURING THE USE OF AN O2 SENSOR APPLIED TO THE PATIENT'S FOOT IN A HOSPITAL SETTING WITH NATURAL LIGHTNING AND SECURED WITH SUPPLEMENTAL TAPE. THE NURSE ON DUTY NOTED PARTICULARLY LOW VALUES ON A MONITOR USING THE SENSOR, WITH A READING OF 79. THE PATIENT WAS DESCRIBED AS CALM AND NOT IN VISIBLE DISTRESS. TO VERIFY THE ACCURACY OF THE READING, THE NURSE USED A PORTABLE MONITOR WITH A GENERIC SENSOR FROM ANOTHER BRAND OF SENSOR, WHICH DISPLAYED A SIGNIFICANTLY HIGHER VALUE OF 99, INDICATING A 20-POINT DISCREPANCY. THE PATIENT¿S SKIN CONDITION AND CIRCULATORY STATUS WERE DESCRIBED AS OKAY. FOLLOWING THE EVENT, THE SENSOR BOX WAS REMOVED FROM USE, AND A REPLACEMENT BOX OF SENSORS WAS SENT TO THE CUSTOMER. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER HOSPITAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228761 ↗
• MalfunctionJan 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT EXPERIENCED A SUPERFICIAL SKIN DAMAGE ON FINGER (BURN). THE SENSOR PLACED AT THE RIGHT INDEX FINGER, AND IT WAS PLACED IN 24 HOURS OF TOTAL USAGE, WITH A LOCATION CHANGE FREQUENCY OF APPROXIMATELY 3 HOURS.

  Patient problems: Burn(s)

  MAUDE report 21089361 ↗
• InjuryNov 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SENSOR CAUSED A BURNING SENSATION WHEN IT WAS IN PLACE. AFTER THE BURNING SENSATION, THE PATIENT EXPERIENCED PAIN IN THE FINGER AND DEVELOPED A DIFFICULT-TO-TREAT WHITLOW, REQUIRING TWO DRAINAGES. INITIALLY, THERE WERE NO VISIBLE SIGNS OR TRAUMA NOTED BY THE HEALTHCARE TEAM. THE PATIENT LATER RETURNED TO THE EMERGENCY ROOM AFTER GOING HOME, WITH A PERSISTENT WHITLOW AT THE SENSOR'S PLACEMENT SITE, WHICH DID NOT RESPOND WELL TO LOCAL TTT. THE SENSOR WAS CHANGED EVERY 3-4 HOURS PRIOR TO THE EVENT.

  Patient problems: Skin Burning Sensation

  MAUDE report 20733294 ↗
• MalfunctionNov 6, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE SENSOR HAD LOW SPO2 READING THAT COULD BE SEEN ON DIFFERENT MONITORS. THE FIRST SENSOR WAS PLACED AT THE PATIENT'S FOOT AND THE BASELINE VALUES WERE BETWEEN 7-20% (DEPENDS ON THE LEVEL OF SATURATION). SPO2 WAS UNDER ALARM LIMIT AND WAS IN SILENT MODE. DUE TO THE INCORRECT READINGS (A HIGH DOWNWARD DEVIATION), AN UNNECESSARY ARTERIAL BLOOD GAS (ABG) WAS PERFORMED. THE SECOND SENSOR WAS USED FOR INVESTIGATION BUT THE ISSUE ALSO OCCURRED. IT WAS CHECKED WITH TWO DIFFERENT SATURATION SIMULATORS WHICH RESULTED THAT AS LOWER THE SATURATION WAS SET, A HIGHER WAS THE DEVIATION DOWNWARDS. THIRD SENSOR WAS USED AND IT WORKED EFFECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625477 ↗
• MalfunctionNov 6, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE SENSOR HAD LOW SPO2 READING THAT COULD BE SEEN ON DIFFERENT MONITORS. THE FIRST SENSOR WAS PLACED AT THE PATIENT'S FOOT AND THE BASELINE VALUES WERE BETWEEN 7-20% (DEPENDS ON THE LEVEL OF SATURATION). SPO2 WAS UNDER ALARM LIMIT AND WAS IN SILENT MODE. DUE TO THE INCORRECT READINGS (A HIGH DOWNWARD DEVIATION), AN UNNECESSARY ARTERIAL BLOOD GAS (ABG) WAS PERFORMED. THE SECOND SENSOR WAS USED FOR INVESTIGATION BUT THE ISSUE ALSO OCCURRED. IT WAS CHECKED WITH TWO DIFFERENT SATURATION SIMULATORS WHICH RESULTED THAT AS LOWER THE SATURATION WAS SET, A HIGHER WAS THE DEVIATION DOWNWARDS. THIRD SENSOR WAS USED AND IT WORKED EFFECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623182 ↗
• MalfunctionJun 14, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW OXYGEN SATURATION (SPO2) READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LIGHT-EMITTING DIODE (LED) LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543467 ↗
• MalfunctionJun 14, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW OXYGEN SATURATION (SPO2) READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LIGHT-EMITTING DIODE (LED) LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542809 ↗
• MalfunctionJun 14, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW OXYGEN SATURATION (SPO2) READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LIGHT-EMITTING DIODE (LED) LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542798 ↗
• MalfunctionJun 14, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW OXYGEN SATURATION (SPO2) READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LIGHT-EMITTING DIODE (LED) LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542785 ↗
• MalfunctionMay 23, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW SPO2 READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379657 ↗
• MalfunctionMay 22, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW SPO2 READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378657 ↗
• MalfunctionMay 22, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW SPO2 READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378651 ↗
• MalfunctionMay 22, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW SPO2 READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378649 ↗
• MalfunctionMay 22, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW SPO2 READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378647 ↗
• MalfunctionMay 1, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW SPO2 READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219126 ↗
• MalfunctionMay 1, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW SPO2 READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219123 ↗
• MalfunctionMay 1, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW SPO2 READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219122 ↗
• MalfunctionApr 30, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW OXYGEN SATURATION (SPO2) READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217725 ↗
• MalfunctionApr 30, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW OXYGEN SATURATION (SPO2) READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217711 ↗
• MalfunctionApr 30, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW OXYGEN SATURATION (SPO2) READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217693 ↗
• MalfunctionApr 30, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW OXYGEN SATURATION (SPO2) READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19216938 ↗
• MalfunctionApr 30, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW OXYGEN SATURATION (SPO2) READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19216133 ↗
• MalfunctionApr 30, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW OXYGEN SATURATION (SPO2) READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215977 ↗
• MalfunctionApr 30, 2024Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information; Erratic or Intermittent Display; Failure to Analyze Signal; Low Readings; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW OXYGEN SATURATION (SPO2) READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215735 ↗
• MalfunctionFeb 2, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE SHOWED LOW VALUES. DURING THE STAY AT THE NEONATOLOGY DEPARTMENT, THE PATIENT RECOVERED AND LEVELED OFF AT 94 - 98% WITHOUT OXYGEN SATURATION. WHEN THE PATIENT WAS TAKEN OVER, THERE WAS A SUDDEN DROP IN SATURATION AND THE PATIENT SUDDENLY HAD O² SATURATION BETWEEN 88 AND 90% DESPITE A VERY GOOD AZ AND CALM BREATHING. THE PATIENT WAS NOT OBSTRUCTIVE, SHOWED NO SYMPTOMS AND THE BREATHING RATE WAS ABSOLUTELY NORMAL, THE VALUES FROM NEONATOLOGY WERE CORRECT. THE USER CHANGED THE CABLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636810 ↗

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.