Nellcor PM10NRecalls & reported problems

Summary

The FDA's MAUDE database contains 200 adverse event reports that list this exact device (DI 20884521208787), received between Jul 20, 2017 and Jun 1, 2026 — classified as 2 deaths, 1 injury, 197 malfunctions.

The most frequently reported specific device problem is “Low Readings” (66 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 200 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Device Alarm System; Data Problem

  IT WAS REPORTED THAT A DEVICE WAS OBSERVED WHILE PREPARING FOR USE TO NOT HOLD THE DATE AND TIME (TIME CLOCK ISSUE). THERE WERE NO AUDIBLE AND VISUAL ALARMS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349685 ↗
• MalfunctionMay 29, 2026Failure to Analyze Signal; Low Readings

  IT WAS REPORTED THAT, DURING USE, THE DEVICE WAS TAKING TOO LONG TO OBTAIN A READING AND WAS READING LOW OR INCORRECTLY WITH REPORTED VALUES OF SPO2 77 AND PULSE RATE 22. SENSOR WAS PLACED CORRECTLY AND PATIENT WAS IN SEATED POSITION. THE USER TESTED THE SENSOR ON THEMSELVES AND OBSERVED THE SAME READINGS. SENSORS WERE SWAPPED OUT TO ISOLATE FAILURE. THE USER SWITCHED MONITORS AND NOTICED THE OTHER PULSE OX MONITOR WAS READING PROPERLY. THE MONITOR WAS THEN TURNED ON AND OFF TO RESET IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333454 ↗
• MalfunctionMay 20, 2026Device Alarm System; Low Readings

  DURING INTRAOPERATIVE USE, THE MONITOR DID NOT READ CORRECTLY FOR A NEONATE/PEDIATRIC PATIENT, AND LOW OXIMETRY READINGS WERE OBSERVED. NO ALARM OCCURRED AT THE TIME THE ISSUE WAS NOTED. COMPATIBILITY OF THE CABLES USED WITH THE UNIT WAS CONSIDERED AS A POSSIBLE FACTOR. TROUBLESHOOTING WAS PERFORMED, INCLUDING CHECKING PROPER PATIENT SENSOR PLACEMENT, CONSIDERING THE EFFECTS OF LIGHT-EMITTING DIODE (LED) LIGHTING AND PATIENT MOVEMENT, INSPECTING THE SENSOR, AND CONFIRMING THE SENSOR AGE (FROM 2019). A REPLACEMENT SENSOR WAS SUGGESTED TO DETERMINE WHETHER THE READINGS WOULD CHANGE. THE PATIENT TYPE AND WEIGHT SETTINGS ON THE DEVICE WERE ALSO VERIFIED. A REFERENCE GUIDE FOR SENSORS AND PLACEMENT, ALONG WITH INSTRUCTIONS FOR USE INFORMATION, WAS PROVIDED VIA EMAIL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229045 ↗
• MalfunctionMay 18, 2026Device Alarm System; Low Readings

  IT WAS REPORTED THAT DURING INTRAOPERATIVE USE, THE MONITOR DID NOT READ CORRECTLY FOR A NEONATE/PEDIATRIC PATIENT, AND LOW OXIMETRY READINGS WERE OBSERVED. NO ALARM OCCURRED AT THE TIME THE ISSUE WAS NOTED. COMPATIBILITY OF THE CABLES USED WITH THE UNIT WAS CONSIDERED AS A POSSIBLE FACTOR. TROUBLESHOOTING WAS PERFORMED, INCLUDING CHECKING PROPER PATIENT SENSOR PLACEMENT, CONSIDERING THE EFFECTS OF LIGHT-EMITTING DIODE (LED) LIGHTING AND PATIENT MOVEMENT, INSPECTING THE SENSOR, AND CONFIRMING THE SENSOR AGE (FROM 2019). A REPLACEMENT SENSOR WAS SUGGESTED TO DETERMINE WHETHER THE READINGS WOULD CHANGE. THE PATIENT TYPE AND WEIGHT SETTINGS ON THE DEVICE WERE ALSO VERIFIED. A REFERENCE GUIDE FOR SENSORS AND PLACEMENT, ALONG WITH INSTRUCTIONS FOR USE INFORMATION, WAS PROVIDED VIA EMAIL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210064 ↗
• MalfunctionApr 15, 2026Device Alarm System; Low Readings; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING USE, THE MONITOR WAS PROVIDING LOW SPO2 READINGS. THE MONITOR WAS CONSISTENTLY READING LOW, DISPLAYING SPO2 VALUES OF 66¿71% AND PULSE RATES OF 78¿81 BPM, REGARDLESS OF THE SETTINGS APPLIED ON THE PATIENT SIMULATOR. A PATIENT SIMULATOR WAS USED, AND EVEN WHEN SET TO 95% SPO2 AND 140 BPM, THE MONITOR DID NOT REFLECT THESE VALUES AND DID NOT ALARM AS EXPECTED. THE PATIENT SIMULATOR HAD BEEN CALIBRATED WITHIN THE LAST MONTH. SENSORS WERE SWAPPED, INCLUDING THE USE OF A SENSOR PROBE THAT WAS VERIFIED TO BE FUNCTIONING PROPERLY ON ANOTHER MONITOR; HOWEVER, THE SAME LOW READINGS WERE OBSERVED. THE READINGS WERE ALSO COMPARED TO ANOTHER UNIT. IT WAS NOTED TO CHECK THE SPO2 SETTINGS, PATIENT SETTINGS/MODES, AND TO CONFIRM THAT THE CORRECT DATA WAS BEING RECEIVED FROM THE DEVICE WHEN VERIFYING WITH THE TESTER. ADDITIONALLY, IT WAS RECOMMENDED TO REMOVE THE DEVICE FROM ANY LED LIGHTING TO RULE OUT INTERFERENCE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889454 ↗
• MalfunctionApr 14, 2026Image Display Error/Artifact; Low Readings

  IT WAS REPORTED THAT DURING TESTING/MAINTENANCE, THE DEVICE EXHIBITED READINGS APPROXIMATELY 6 TO 7 POINTS LOWER THAN A SIMULATOR, AND WAS GIVING INTERMITTENT FAILURES SUCH AS SYSTEM FAILURE AND SPO2 FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873169 ↗
• MalfunctionApr 3, 2026Low Readings

  IT WAS REPORTED THAT LOW READINGS WERE OBSERVED WITH THE OXIMETRY DEVICE. THE CIRCUMSTANCES UNDER WHICH THE ISSUE WAS OBSERVED AND ANY PATIENT INVOLVEMENT OR COMPLICATIONS WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24781588 ↗
• MalfunctionMar 23, 2026Device Alarm System; Image Display Error/Artifact; Data Problem

  IT WAS REPORTED THAT THE UNIT WAS DISPLAYING ERROR CODE 907, IDENTIFIED AS A REAL-TIME CLOCK ERROR. THE UNIT DID NOT ALARM WHEN THE ERROR OCCURRED AND CONTINUED PROVIDING READINGS. IT WAS COMMUNICATED THAT THE DATE AND TIME COULD BE UPDATED BUT WOULD REVERT TO ANINCORRECT SETTING. IT WAS NOTED THAT REPLACING THE COIN CELL BATTERY CAN SOMETIMES CLEAR THE MESSAGE, BUT IN SOME CASES THE ERROR PERSISTS AND THE UNIT REQUIRES SERVICING. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670819 ↗
• MalfunctionFeb 16, 2026Device Alarm System; Image Display Error/Artifact; Failure to Analyze Signal

  IT WAS REPORTED THAT THE DEVICE WAS SHOWING SYSTEM FAILURE, WAS NOT READING PULSE OR SPO2, AND THE DEVICE ALARM FAILED WHEN THE MALFUNCTION OCCURRED. TROUBLESHOOTING STEPS INCLUDED SWAPPING CABLES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343232 ↗
• MalfunctionDec 23, 2025Device Alarm System; Image Display Error/Artifact; Device Alarm System; Image Display Error/Artifact

  IT WAS REPORTED THAT A UNIT DISPLAYED ERROR 907, IDENTIFIED AS A REAL TIME CLOCK ERROR. THE DATE AND TIME COULD BE UPDATED BUT WOULD REVERT BACK TO AN INCORRECT SETTING. IT WAS NOTED THAT REPLACING THE COIN CELL BATTERY MAY CLEAR THE ERROR MESSAGE IN SOME CASES, BUT NOT ALWAYS. UNIT DID NOT ALARM WHEN ERROR OCCURRED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885630 ↗
• MalfunctionDec 16, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE UNIT HAD INCORRECT VALUES. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817946 ↗
• MalfunctionOct 28, 2025Device Alarm System; Image Display Error/Artifact; Device Alarm System; Image Display Error/Artifact

  IT WAS REPORTED THAT PRIOR TO USE, THE UNIT WOULD NOT TURN ON AT FIRST. THE BATTERY WAS FOUND FLATTENED OUT AND WAS ADJUSTED. THE UNIT WAS THEN TURNED ON AND HAD ERROR 907. THE UNIT DID NOT ALARM WHEN THE MALFUNCTION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403947 ↗
• MalfunctionSep 18, 2025Device Alarm System; Image Display Error/Artifact; Device Alarm System; Image Display Error/Artifact

  IT WAS REPORTED THAT A UNIT DISPLAYED ERROR CODE 907, WHICH IS A REAL TIME CLOCK ERROR MESSAGE. THE UNIT DID NOT ALARM WHEN THE ERROR OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084213 ↗
• MalfunctionSep 10, 2025Device Alarm System; Image Display Error/Artifact; Failure to Run on Battery; Failure to Power Up; Device Alarm System; Image Display Error/Artifact; Failure to Run on Battery; Failure to Power Up

  IT WAS REPORTED THAT DURING TESTING AND MAINTENANCE, THE MONITOR DISPLAYED ERROR 907 AND THE COIN CELL BATTERY REQUIRED REPLACEMENT. TROUBLESHOOTING STEPS INCLUDED ATTEMPTING TO REPLACE THE COIN CELL BATTERY, AND ASSISTANCE WAS PROVIDED TO WALK THROUGH THE REPLACEMENT PROCESS. THE CUSTOMER WAS ABLE TO SUCCESSFULLY DISASSEMBLE THE MONITOR AND REPLACE THE COIN CELL BATTERY.  THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013317 ↗
• MalfunctionAug 29, 2025Device Alarm System; Incorrect Measurement; Device Alarm System; Incorrect Measurement

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE PATIENT'S BLOOD OXYGEN SATURATION READINGS WERE INACCURATE AND DEVICE DID NOT ALARM. THE MONITOR WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929331 ↗
• MalfunctionAug 20, 2025Device Alarm System; Failure to Power Up; Device Damaged Prior to Use; Device Alarm System; Failure to Power Up; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON, EXHIBITED CASE DAMAGE, AND HAD MAIN BOARD COMPONENTS THAT WERE DAMAGED. NO AUDIBLE OR VISIBLE ALARMS WERE TRIGGERED FOR THE FAILURE. BOTH THE FRONT CASE AND MAIN BOARD WERE REPLACED, AND THE SYSTEM SOFTWARE WAS UPDATED. THE DEVICE ARRIVED WITHOUT ANY BATTERIES. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22850563 ↗
• MalfunctionAug 12, 2025Device Alarm System; Failure to Power Up; Device Alarm System; Failure to Power Up

  IT WAS REPORTED THAT DURING PREPARATION FOR USE IN A BIRTHING CENTER, THE DEVICE WOULD NOT TURN ON AND THE DEVICE ALARM DID NOT ACTIVATE WHEN IT SHOULD HAVE. BATTERIES WERE SWAPPED AS A TROUBLESHOOTING STEP, AND THE ISSUE WAS ISOLATED TO THE DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22785147 ↗
• MalfunctionAug 11, 2025Incorrect Measurement; Low Readings; Incorrect Measurement; Low Readings

  IT WAS REPORTED THAT DURING USE, THE SENSOR PROVIDED LOW AND INCORRECT OXIMETRY READINGS. THE SAME SENSOR WAS TESTED ON A DIFFERENT DEVICE AND GAVE CORRECT READINGS, WHILE ANOTHER SENSOR TESTED ON THE ORIGINAL DEVICE SHOWED NO CHANGE. A COMPARISON OF FINGER SENSOR READINGS TO FOREHEAD SENSOR READINGS INDICATED THAT THE FOREHEAD READINGS WERE BETTER, WHILE THE FINGER SENSOR CONTINUED TO DISPLAY LOWER SPO2 VALUES. TROUBLESHOOTING STEPS INCLUDED SWAPPING SENSORS AND DEVICES 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 22770975 ↗
• MalfunctionAug 11, 2025Device Alarm System; Image Display Error/Artifact; Failure to Power Up; Device Alarm System; Image Display Error/Artifact; Failure to Power Up

  IT WAS REPORTED THAT THE DEVICE CYCLED POWER BY ITSELF AND SOMETIMES DISPLAYED A 920 ERROR DURING PREPARATION FOR USE IN A BIRTHING CENTER. THE DEVICE DID NOT ALARM WHEN IT SHOULD HAVE. BATTERIES WERE SWAPPED AS A TROUBLESHOOTING STEP, AND THE ISSUE WAS ISOLATED TO THE DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770618 ↗
• MalfunctionAug 1, 2025Device Alarm System; Image Display Error/Artifact; Device Alarm System; Image Display Error/Artifact

  IT WAS REPORTED THAT PRIOR TO USE, THE UNIT DISPLAYED ERROR 907 AND DID NOT ALARM DURING PRE-OPERATIVE PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690326 ↗
• MalfunctionAug 1, 2025Device Alarm System; Failure to Analyze Signal; Device Alarm System; Failure to Analyze Signal

  IT WAS REPORTED THAT THE UNIT WOULD NOT READ SPO2 WHEN A SENSOR WAS ATTACHED AND DID NOT PRODUCE AN ALARMING SOUND OR ERROR MESSAGE DURING TESTING AND MAINTENANCE. THE UNIT WAS POWER CYCLED, THE SENSOR WAS REPLACED WITH A WORKING NEW SENSOR, AND SENSORS WERE SWAPPED TO ISOLATE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690317 ↗
• MalfunctionJul 15, 2025Incorrect Measurement; High Readings; Incorrect Measurement; High Readings

  IT WAS REPORTED THAT DURING USE, THERE WERE MULTIPLE ISSUES WITH THE MONITOR; HIGH PULSE RATE READINGS AND INCONSISTENT SPO2 READINGS. THE PULSE RATE READING DID NOT MATCH THE MANUAL CHECK HEART PULSE RATE; THE MONITOR DISPLAYED A RATE READING OF 250, WHILE THE MANUAL CHECK SHOWED 152. THE SENSOR AND BATTERIES WERE REPLACED WITH NEW ONES, BUT THE ISSUE PERSISTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509027 ↗
• MalfunctionJul 15, 2025Incorrect Measurement; High Readings; Incorrect Measurement; High Readings

  IT WAS REPORTED THAT DURING USE, THERE WERE MULTIPLE ISSUES WITH THE MONITOR; HIGH PULSE RATE READINGS AND INCONSISTENT SPO2 READINGS. THE PULSE RATE READING DID NOT MATCH THE MANUAL CHECK HEART PULSE RATE; THE MONITOR DISPLAYED A RATE READING OF 180, WHILE THE MANUAL CHECK SHOWED 166 AND 168. THE SENSOR AND BATTERIES WERE REPLACED WITH NEW ONES, BUT THE ISSUE PERSISTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508983 ↗
• MalfunctionJul 15, 2025Image Display Error/Artifact; Low Readings; Image Display Error/Artifact; Low Readings

  IT WAS REPORTED THAT DURING THE EXAMINATION PROCEDURE, THE DEVICE DISPLAYED INACCURATE READINGS, WITH MULTIPLE VALUES FALLING BELOW 95%, AND A REAL-TIME CLOCK ERROR (907) WAS OBSERVED. TROUBLESHOOTING STEPS INCLUDED REPLACING THE COIN CELL BATTERY, REBOOTING THE UNIT, ADJUSTING THE DATE AND TIME, AND CHECKING THE BATTERY CONTACTS; HOWEVER, THESE ACTIONS DID NOT RESOLVE THE ERROR. SYSTEM FAILURE ERROR MESSAGES PERSISTED DESPITE TROUBLESHOOTING EFFORTS. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508642 ↗
• MalfunctionJul 3, 2025Incorrect Measurement; High Readings; Incorrect Measurement; High Readings

  IT WAS REPORTED THAT DURING USE, THERE WERE MULTIPLE ISSUES WITH THE MONITOR; HIGH PULSE RATE READINGS AND INCONSISTENT SPO2 READINGS. THE PULSE RATE READING DID NOT MATCH THE MANUAL CHECK HEART PULSE RATE; THE MONITOR DISPLAYED A RATE READING OF 165, WHILE THE MANUAL CHECK SHOWED 110. THE SENSOR AND BATTERIES WERE REPLACED WITH NEW ONES, BUT THE ISSUE PERSISTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22397139 ↗