Nellcor PM1000NRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884521182530), received between Jan 4, 2019 and Mar 19, 2026 — classified as 2 deaths, 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (18 reports).

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.

• MalfunctionMar 19, 2026Low Readings

  IT WAS REPORTED THAT THE MONITOR SHOWED OXYGENATION BELOW NORMAL. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 24646084 ↗
• MalfunctionJan 23, 2026Device Alarm System; Low Readings

  IT WAS REPORTED THAT THE UNIT WAS PROVIDING LOW READINGS. THE UNIT WAS READING 2¿6 POINTS LOWER THAN EXPECTED. NUMERICAL VALUES OBTAINED 92-96% O2 TWO DIFFERENT SENSORS WERE USED TO CONFIRM THE LOW READINGS. THERE WAS NO AUDIBLE ALARMS. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173020 ↗
• MalfunctionJan 6, 2026Failure to Analyze Signal; Low Readings; Misassembly During Maintenance/Repair

  IT WAS REPORTED THAT, DURING USE, THE DEVICE SHOWED AN ABSENCE OF SPO2 READINGS, REPEATED MONITOR SIGNAL DROPOUTS, PLETHYSMOGRAPHIC PATTERN DROPOUTS, AND A SIGNAL DROPOUT LASTING APPROXIMATELY FIVE SECONDS (WITH SPO2 VALUES IN THE HIGH 90S PRIOR TO THIS). THE MONITOR THEN TURNED ITSELF OFF AND REBOOTED, CAUSING A DELAY IN MONITORING FOR A FEW MINUTES. ALTHOUGH THE MONITOR HAD PREVIOUSLY UNDERGONE SEVERAL REPAIRS AND A SOFTWARE UPDATE, THE ISSUES PERSISTED. THE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977892 ↗
• MalfunctionAug 7, 2025Device Alarm System; Failure to Analyze Signal; Device Alarm System; Failure to Analyze Signal

  IT WAS REPORTED THAT, PRIOR TO USE AND DURING PREPARATION FOR A PROCEDURE, THE MONITOR EXHIBITED NO OXIMETRY READINGS AND WAS BOOTING SLOWLY. NO AUDIBLE OR VISIBLE ALARMS WERE PRESENTED FOR THESE ISSUES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742031 ↗
• MalfunctionJul 30, 2025Device Alarm System; Failure to Analyze Signal; Device Alarm System; Failure to Analyze Signal

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE, THE DEVICE DISPLAYED NO OXIMETRY READINGS AND NO ALARM WAS PRESENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668848 ↗
• MalfunctionApr 22, 2025Image Display Error/Artifact; Temperature Problem; Application Program Freezes or Fails to Launch; Image Display Error/Artifact; Temperature Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT DURING TESTING/MAINTENANCE, THE MONITOR WAS STUCK ON THE LOADING SCREEN, EXHIBITED AN SPO2 ERROR, AND EMITTED A BURNING ODOR. ADDITIONALLY, THE FRONT CASING OF THE DEVICE HAD A CRACK. TROUBLESHOOTING STEPS INCLUDED SWAPPING SENSORS AND SPO2 CORDS, BUT NO CHANGE WAS OBSERVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886030 ↗
• MalfunctionNov 11, 2024Device Alarm System; Image Display Error/Artifact; Device Alarm System; Image Display Error/Artifact

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE MONITOR HAD SOUND ERROR OR ERROR WITH ALARM WHEN POWERED ON. IT WAS UNABLE TO NOTE SOUND AND THERE WAS NO AUDIBLE ALARM. THE ISSUE WAS ISOLATED TO THE MONITOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651022 ↗
• MalfunctionNov 5, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD READINGS OFF. THE UNIT TESTED WAS FOUR POINTS OFF WHEN TRYING TO GET ACCURATE READINGS ON THE UNIT. USED A THIRD PARTY TESTING DEVICE, TRIED THE TESTING DEVICE ON TWO OTHER UNITS SET AT 98 AND THEY CAME UP ACCURATE. WHEN TESTED THE UNIT, IT WAS AT 94. THE UNIT WAS FOUR POINTS LOWER THAN THE OTHER UNIT THAT WAS TESTED ON. WHEN TRIED ON ANOTHER DEVICE, IT WAS AROUND 97/98 WHEN TRIED ON THE UNIT IN QUESTION, IT WAS AT 93/94. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612453 ↗
• MalfunctionJul 18, 2024Incorrect Measurement; Failure to Calibrate; Incorrect Measurement; Failure to Calibrate

  ACCORDING TO THE REPORTER, THE PRODUCT WAS OUT OF CALIBRATION AND WRONG VALUES WERE TRIGGERED WHEN COMPARED TO EVALUATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19774464 ↗
• MalfunctionJun 29, 2023Image Display Error/Artifact; Failure of Device to Self-Test; Noise, Audible; Image Display Error/Artifact; Failure of Device to Self-Test; Noise, Audible

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE UNIT STARTED UP, THE DEVICE PRODUCED A POST(POWER ON SELF-TEST) TONE BUT THE UNIT SHOWED ""ERROR 11, POST TEST FAILURE"" IN THE BANNER. A SPEAKER TEST FAILURE WAS ALSO REPORTED. IT WAS SWAPPED TO ISOLATE THE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17227101 ↗
• MalfunctionJun 7, 2023Device Alarm System; Use of Device Problem; Manufacturing, Packaging or Shipping Problem; Device Alarm System; Use of Device Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT'S LCD TOUCH SCREEN WAS NOT WORKING AT ALL. THE INTERNAL CABLE WAS ABLE TO BE RESEATED AND FIXED THE ISSUE, HOWEVER THE UNIT WAS SILENCING ITSELF. THERE WERE NO AUDIBLE OR VISUAL ALARMS. IT WAS A FAILURE OUT OF BOX. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078476 ↗
• MalfunctionMar 8, 2023Device Alarm System; Image Display Error/Artifact; Device Alarm System; Image Display Error/Artifact

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PRODUCT GAVE ERROR 11, SPEAKER FAILURE. THE PRODUCT WAS POWERED DOWN AND UP WITH NO CHANGE. THERE WAS NO SOUND AT THE END OF POST (POWER ON SELF-TEST) AND THE BACK UP ALARM HAD NO SOUND. THE ALARM WAS NOT SILENCED AND THE VOLUME WAS NOT DECREASED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501997 ↗
• MalfunctionFeb 1, 2023Device Alarm System; Failure to Run on Battery; Failure to Power Up; Failure to Analyze Signal; Loss of Data; Noise, Audible; Delayed Program or Algorithm Execution; Device Alarm System; Failure to Run on Battery; Failure to Power Up; Failure to Analyze Signal; Loss of Data; Noise, Audible; Delayed Program or Algorithm Execution

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT WAS INTERMITTENTLY MALFUNCTIONING WITH GAPS IN TREND DATA, THERE WERE ALARMS AND IT SHUT ITSELF DOWN. THERE WAS ERROR MESSAGE OF SYSTEM FAILURE AND TREND DATA LOST. THE POWER AND BATTERY WERE VERIFIED, AND UNIT WAS RESTARTED. ANALOG OUTPUTS WERE USED TO GET HEART RATE AND SPO2 EXPORTED TO OUTSIDE THE UNIT TO A MONITORING ROOM. THE ALARM BATTERY WAS CRITICALLY INACTIVE. IT HAS LOW BATTERY, SPEAKER FAILURES AND SPO2 PULSE WERE INACTIVE. THE UNIT TYPICALLY GETS TURNED OFF AND ON DURING DAY, BECAUSE IT WAS ONLY USED AT NIGHT. THE MONITOR SETTINGS AVAILABLE WERE HIGH/LOW SPO2: 100/85 HIGH/LOW PULSE: 170/40 BUT THERE WERE NO READINGS AVAILABLE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16278273 ↗
• MalfunctionNov 21, 2022Device Alarm System; Communication or Transmission Problem; Device Alarm System; Communication or Transmission Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NURSE CALL DID NOT ALARM WHEN THE MONITOR ALARMED. IT WAS POWER CYCLED, NURSE CALL CABLE WAS REPLACED AND RECOMMENDED REPLACEABLE BATTERIES WERE REPLACED LAST YEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835673 ↗
• MalfunctionNov 10, 2022Temperature Problem; Application Program Freezes or Fails to Launch; Temperature Problem; Application Program Freezes or Fails to Launch

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD FAINT ELECTRICAL BURNT SMELL AND FROZEN SCREEN ON START UP SCREEN. THE DEVICE WAS POWERED ON. THE UNIT HAD NO FIRE, SMOKE OR SPARK, BUT EXHIBITS ODOR. THE DEVICE DID NOT SHUTDOWN, AND THERE WAS NO FLAME OR SMOKE, NO POWER SURGE NOTED AT THE TIME, USED 120 POWER SOURCE. NO INCLEMENT WEATHER IN THE AREA ON THE TIME OF EVENT, POWER SOURCE AND AND POWER CORD WAS GROUNDED. NO EXTENSION CORD OR POWER STRIP WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776938 ↗
• MalfunctionJun 10, 2022Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, THE PRODUCT DID NOT ALARM. THE USE OF A SENSOR SIMULATOR FOR THE HIGH AND LOW PRESET VALUES DID NOT TRIP THE ALARM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14659129 ↗
• MalfunctionMar 17, 2022Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING USE, THE SPO2 WAS SPOT ON BUT THE HEART RATE WAS ALWAYS ALL OVER THE PLACE AND INCORRECT. TRIED A TESTER, POWER CYCLED THE UNIT. CUSTOMER NOTED SPO2 WAS SPOT ON BUT THE HEART RATE WAS ALWAYS ALL OVER THE PLACE AND INCORRECT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13798726 ↗
• MalfunctionJan 21, 2022Device Alarm System; Noise, Audible; Device Alarm System; Noise, Audible

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS A SPEAKER FAILURE WITH THE UNIT. NO BACKUP ALARMS SOUNDED FROM THE UNIT. THE USER ORIGINALLY HEARD BEEPS, HOWEVER, IT FADED SINCE THEN AND IT KEPT ON HAPPENING. THE UNIT WAS POWER CYCLED AS A TROUBLESHOOTING STEP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314055 ↗
• MalfunctionMay 25, 2021Device Alarm System; Low Readings; Device Alarm System; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT CONVULSED AND THE MONITOR DID NOT SOUND. THE SCREEN DID NOT INDICATE ANYTHING.

  Patient problems: Convulsion/Seizure

  MAUDE report 11874197 ↗
• InjuryMay 13, 2021Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT WITH TRACHEOSTOMY CANNULA DECANNULATED WHILE SLEEPING. IT WAS THE VENTILATOR THAT ALARMED AND ALERTED THE HEALTHCARE TEAM. THE REPORTED SPO2 MONITORING DEVICE DID NOTHING WHEN THE PATIENT DESATURATED WITH A READING OF 52%.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11821310 ↗
• MalfunctionMar 22, 2021Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE PRODUCT GAVE LOW READINGS. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543881 ↗
• MalfunctionDec 30, 2020Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN SATURATION PATTERN DETECTION (SPD) WAS ACTIVATED, SATSECONDS OF 25 WOULD NOT ALARM WHEN CIRCLE ICON IS FULL (ALARMS AT 100 SATSECONDS). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094300 ↗
• MalfunctionDec 30, 2020Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN SATURATION PATTERN DETECTION (SPD) WAS ACTIVATED, SATSECONDS OF 25 WOULD NOT ALARM WHEN CIRCLE ICON IS FULL (ALARMS AT 100 SATSECONDS). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094259 ↗
• MalfunctionDec 30, 2020Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN SATURATION PATTERN DETECTION (SPD) WAS ACTIVATED, SATSECONDS OF 25 WOULD NOT ALARM WHEN CIRCLE ICON IS FULL (ALARMS AT 100 SATSECONDS). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094233 ↗
• MalfunctionDec 29, 2020Device Alarm System; Device Alarm System

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN SATURATION PATTERN DETECTION (SPD) WAS ACTIVATED, SATSECONDS OF 25 WOULD NOT ALARM WHEN CIRCLE ICON IS FULL (ALARMS AT 100 SATSECONDS). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085641 ↗