Nellcor PM100NRecalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 10884521196728), received between Aug 22, 2017 and Apr 9, 2026 — classified as 9 deaths, 5 injuries, 128 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (47 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 23, 2025Open, Classified

   Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting

   Z-2151-2025 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 142 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026High Readings

  IT WAS REPORTED THAT HIGH READINGS WERE OBSERVED ON THE DEVICE, WITH VALUES APPEARING TO BE SLIGHTLY HIGHER THAN USUAL. NO COMPLICATIONS OR HARMS WERE REPORTED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832030 ↗
• DeathJan 12, 2026Device Alarm System

  IT WAS REPORTED THAT DURING USE, THE MONITOR FAILED TO ALARM, RESULTING IN THE PATIENT¿S DEATH.

  Patient problems: Brain Injury

  MAUDE report 24037582 ↗
• MalfunctionDec 4, 2025Device Alarm System; Image Display Error/Artifact; Device Alarm System; Image Display Error/Artifact

  IT WAS REPORTED THAT DURING TESTING AND MAINTENANCE OF THE DEVICE, AN ERROR CODE 804 SPO2 COMMUNICATION ERROR OCCURRED AND THE ALARM FAILED WHEN THE MALFUNCTION OCCURRED. TROUBLESHOOTING STEPS INCLUDED SWAPPING WITH A KNOWN WORKING CABLE AND SENSORS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715924 ↗
• MalfunctionSep 16, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT THE MONITOR PROVIDED LOWER READINGS COMPARED TO OTHER UNITS DURING INTRAOPERATIVE USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066784 ↗
• MalfunctionSep 12, 2025Device Alarm System; Failure to Power Up; Device Alarm System; Failure to Power Up

  IT WAS REPORTED THAT WHILE THE DEVICE WAS IN USE ON A PATIENT DURING A PROCEDURE, THE UNIT WAS FOUND TO BE TURNED OFF. THERE WAS A POTENTIAL ALLEGATION THAT THE DEVICE MAY HAVE RUN OUT OF BATTERY LIFE WHILE IN USE ON THE PATIENT. THE DEVICE WAS SENT FOR EVALUATION, WHERE IT WAS TESTED WITH A SIMULATOR AND FOUND TO BE FUNCTIONING WITHOUT ANY ISSUES. BIOMED REASONED THAT THE UNIT MAY HAVE RUN OUT OF BATTERY LIFE DURING USE AND ACKNOWLEDGED THAT THE BATTERY COULD HAVE BEEN DEAD WHEN THEY RECEIVED THE UNIT. THE DEVICE WAS NOT SENT IN FOR REPAIRS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23045105 ↗
• MalfunctionAug 26, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT ERRATIC READINGS WERE OBSERVED WITH THE OXIMETRY FUNCTION OF THE MONITOR.  THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894155 ↗
• DeathAug 14, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE MONITOR, A DELAYED ALARM NOTIFICATION AND DEVICE ALARM SYSTEM ISSUE OCCURRED WHILE MONITORING THE PATIENT WHO WAS RECEIVING A FULL-TIME CARE AT HOME. THE DEVICE WAS CONFIGURED TO ALERT FOR OXYGEN DESATURATION AND BRADYCARDIA. ON THE DATE OF THE EVENT, THE PATIENT EXPERIENCED BRADYCARDIA, CARDIAC ARREST, LOW OXYGEN SATURATION, RESPIRATORY ARREST, AND DEATH. IT WAS ALLEGED THAT THE DELAYED ALARM NOTIFICATION MAY HAVE AFFECTED THE ABILITY TO RESPOND QUICKLY DURING A CRITICAL DESATURATION EVENT, POTENTIALLY IMPACTING THE OPPORTUNITY TO STIMULATE AND RESUSCITATE THE PATIENT BEFORE REACHING AN UNRECOVERABLE STATE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22804809 ↗
• MalfunctionAug 8, 2025High Readings; High Readings

  IT WAS REPORTED THAT THE MONITOR GAVE HIGHER READINGS THAN THE HOSPITAL MONITOR BY 7 UNITS DURING INTRA-OPERATIVE USE. TROUBLESHOOTING INCLUDED TESTING WITH ANOTHER NEW SENSOR, BUT THERE WAS NO CHANGE IN THE READINGS, AND THE DEVICE WAS SWAPPED TO ISOLATE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754959 ↗
• DeathAug 4, 2025Device Alarm System; Failure to Analyze Signal; Device Alarm System; Failure to Analyze Signal

  IT WAS REPORTED THAT THE PATIENT HAD BEEN USING THE MONITOR, WHICH WAS CONNECTED TO THE DEVICE AND APPEARED TO BE FUNCTIONING AS EXPECTED WHEN THE VIDEO MONITOR WAS CHECKED AT 3:00 AM. HOWEVER, BY 7:00 AM, THE OXYGEN SATURATION LEVEL HAD DROPPED TO 50, AND THE MONITOR WAS FLASHING BUT NOT ALARMING. THE PATIENT HAD TURNED BLUE, PROMPTING CPR TO BE INITIATED AND 911 TO BE CALLED. THE PATIENT WAS RESUSCITATED AND TRANSPORTED TO THE HOSPITAL, WHERE HE WAS DIAGNOSED WITH HYPOXIC-ISCHEMIC ENCEPHALOPATHY (HIE), A BRAIN INJURY CAUSED BY INSUFFICIENT OXYGEN SUPPLY. UNFORTUNATELY, THE PATIENT WAS RENDERED BRAIN-DEAD AS A RESULT OF THE INCIDENT-FROM (B)(6)-IT WAS REPORTED THAT DURING USE, THE UNIT FLASHED BUT WITH NO AUDIBLE SOUND WHEN THE PATIENT¿S SPO2 WENT DOWN TO 50% AND THE PATIENT TURNED BLUE. THE MOTHER STARTED CPR AND 911 WAS CALLED. THE SON WAS RESUSCITATED AND WAS TAKEN TO THE HOSPITAL BUT WAS LATER DIAGNOSED WITH HYPOXIC-ISCHEMIC ENCEPHALOPATHY (HIE) THAT RENDERED THE PATIENT BRAIN DEAD. THE UNIT WAS REPORTED NOT IN SLEEP STUDY MODE AND HAD AUDIBLE ALARM PRIOR TO THE EVENT. DUPLICATE OF (B)(6).

  Patient problems: Brain Injury; Cyanosis; Encephalopathy; Ischemia

  MAUDE report 22705536 ↗
• MalfunctionJul 22, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE MONITOR WAS FOUND IN A ROOM ON A SHELF WITH A NOTE STATING THAT THE DEVICE WAS NOT ALARMING DURING TESTING AND MAINTENANCE. NO TROUBLESHOOTING STEPS WERE TAKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565007 ↗
• MalfunctionJul 17, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT PRIOR TO USE, THE MONITOR DID NOT ALARM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530854 ↗
• DeathJul 14, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE, THE MONITOR FAILED TO ALARM, RESULTING IN THE PATIENT'S CARDIAC ARREST AND SUBSEQUENT DEATH.

  Patient problems: Cardiac Arrest

  MAUDE report 22493536 ↗
• MalfunctionJun 13, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE MONITOR'S O2 READINGS WERE DROPPING BELOW LIMIT INTERMITTENTLY. THE O2 LEVEL DROPPED BUT SEEMED NO CHANGE TO THE PATIENT. THERE WAS PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 22206318 ↗
• MalfunctionMay 22, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING USE, THE MONITOR HAD AN INACCURATE READINGS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069912 ↗
• MalfunctionMay 20, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT SPO2 VALUES WAS INCORRECT. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22052113 ↗
• MalfunctionMay 8, 2025Image Display Error/Artifact; Low Readings; Image Display Error/Artifact; Low Readings

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE USE, THE UNIT DISPLAYED ERROR EEE010 AND LOW READINGS WERE OBSERVED. THE READING WAS CONSISTENTLY OFF BY -10, READING LOWER THAN EXPECTED. THE SENSOR WAS APPLIED TO THE FINGER, TOES, AND FOOT, HELD IN PLACE WITH MEDICAL TAPE, AND WAS BRAND NEW, HAVING BEEN IN USE FOR ONE DAY. TROUBLESHOOTING STEPS INCLUDED SWAPPING OUT SENSORS WITH KNOWN WORKING AND NEW SENSORS, BUT NO CHANGE WAS OBSERVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985582 ↗
• MalfunctionMay 7, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE MONITOR EXPERIENCED INACCURATE READINGS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977852 ↗
• MalfunctionApr 30, 2025High Readings; Low Readings; High Readings; Low Readings

  IT WAS REPORTED THAT DURING USE, THE DEVICE WAS GIVING ERRATIC READINGS, MOSTLY HIGH. THE CALLER ADVISED THAT THEY HAD SWAPPED OUT CABLES AND SENSORS, BUT THERE WAS NO CHANGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934193 ↗
• MalfunctionApr 18, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PRODUCT DID NOT CAPTURE CORRECTLY AND MADE ERRONEOUS SATURATION CURVES. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21866933 ↗
• MalfunctionApr 3, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE UNIT DID NOT ALARM. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21761336 ↗
• MalfunctionMar 28, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE KEPT FAILING THE BUZZER SYSTEM TEST. IT GAVE NO BUZZER SOUND. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21726547 ↗
• DeathMar 17, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT A PATIENT WAS CO-SLEEPING WITH PARENTS AND USING A SPO2 MONITORING DEVICE WHEN THE PATIENT PASSED AWAY WHILE SLEEPING OVERNIGHT. THE FAMILY STATED THAT THE DEVICE DID NOT ALARM AT THE TIME OF THE PATIENT'S DEATH. THE PATIENT, A 2-MONTH-OLD FEMALE WEIGHING 4 KG, WAS EXPERIENCING RESPIRATORY DISTRESS SYNDROME OF NEWBORNS.

  Patient problems: Distress

  MAUDE report 21618030 ↗
• MalfunctionMar 12, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THERE WERE INACCURATE READINGS FROM A DEVICE WHILE IT WAS ON A PATIENT, DURING USE. THE DEVICE WAS SUBSEQUENTLY SWAPPED OUT. TROUBLESHOOTING STEPS INCLUDED SWAPPING CABLES AND SENSORS, CONFIRMING PLACEMENT, PATIENT MODE, AND SIZE, AND ISOLATING THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590604 ↗
• MalfunctionFeb 18, 2025Erratic or Intermittent Display; Incorrect Measurement; Erratic or Intermittent Display; Incorrect Measurement

  IT WAS REPORTED THAT THE MONITOR HAD INACCURATE AND ERRATIC READINGS. TROUBLESHOOTING STEPS INCLUDED PROVIDING THE CUSTOMER WITH A COMMON ERROR CODE SHEET AND ADVISING THEM TO CHECK CABLES, SENSORS, AND CORDS ON THE UNIT, AS WELL AS PATIENT TYPE AND PLACEMENT. THE DEVICE WAS SWAPPED TO ISOLATE THE ISSUE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21396334 ↗
• MalfunctionFeb 18, 2025Erratic or Intermittent Display; Image Display Error/Artifact; Incorrect Measurement; Erratic or Intermittent Display; Image Display Error/Artifact; Incorrect Measurement

  IT WAS REPORTED THAT THE MONITOR EXHIBITED INACCURATE AND ERRATIC READINGS, ALONG WITH A SYSTEM ERROR 010. TROUBLESHOOTING STEPS INCLUDED PROVIDING THE CUSTOMER WITH A COMMON ERROR CODE SHEET AND ADVISING CHECKS ON CABLES, SENSORS, AND CORDS, AS WELL AS PATIENT TYPE AND PLACEMENT. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21395208 ↗