Nellcor PM1000N-RRRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521182547), received between Nov 15, 2017 and Mar 23, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Use of Device Problem; Low Readings

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE OF THE MONITOR, LOW READINGS ON THE UNIT AND THE TOUCH SCREEN BEING OFF WERE OBSERVED. TROUBLESHOOTING STEPS INCLUDED CHECKING THE READINGS WITH A SENSOR TESTER TO CONFIRM ACCURACY AND NOTING THAT A TOUCH SCREEN CALIBRATION OPTION WAS AVAILABLE IN THE DEVICE¿S SERVICE MENU. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670851 ↗
• MalfunctionNov 13, 2025Device Alarm System; No Display/Image; Device Alarm System; No Display/Image

  IT WAS REPORTED THAT, PRIOR TO USE, THE DEVICE DISPLAYED A BLANK SCREEN. THE AUDIO AND VISUAL ALARMS DID NOT ACTIVATE DURING THE FAILURE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23549976 ↗
• MalfunctionAug 1, 2025Device Alarm System; Failure of Device to Self-Test; Device Alarm System; Failure of Device to Self-Test

  IT WAS REPORTED THAT DURING TESTING AND MAINTENANCE, THE UNIT DID NOT COMPLETE START UP, DID NOT ALARM, AND HUNG ON THE START UP PROCESS. TROUBLESHOOTING STEPS INCLUDED POWER CYCLING THE UNIT AND REPLACING THE BATTERY TO ISOLATE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22691171 ↗
• InjuryDec 13, 2024Failure to Power Up; Material Split, Cut or Torn; Failure to Power Up; Material Split, Cut or Torn

  IT WAS REPORTED THAT A LASER SCANNER EXPERIENCED SHUTTING DOWN SUDDENLY, NOT TURNING ON, AND POWERING UP OR DOWN BY ITSELF, WHICH RISKED PATIENT SAFETY. THE ISSUES WERE OBSERVED DURING USE.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 20925245 ↗
• MalfunctionNov 6, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, THE DEVICE'S SPO2 VALUE WAS HIGH. THE USER DID UNPLUGGING AND PLUGGING IN THE SENSOR CABLE, BUT THERE WAS NO IMPROVEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622088 ↗
• MalfunctionSep 2, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE UNIT HAD NO RELIABLE READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20120490 ↗
• MalfunctionFeb 5, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE LITERATURE, THE DEVICE HAD A DISCREPANCY IN SP02 MEASUREMENT, AN EXCEPTIONAL ERROR OF 17% WAS OBTAINED IN SP02 MEASUREMENT IN AN EXAMINATION WHERE SAO2 WAS 70%, THE ARTICLE DID NOT GO INTO FURTHER DETAIL ABOUT THE ERROR. THE CORRELATION COEFFICIENT BETWEEN THE DEVICE'S SPO2 AND SAO2 WAS 0.776, AND AFTER REMOVING THE MEASUREMENT WITH A 17% DISCREPANCY, THE CORRELATION COEFFICIENT INCREASED TO 0.857. THE CORRELATION COEFFICIENT BETWEEN SPO2 AND SAO2 WAS 0.845. THE POSITIVE VALUE OF THE MEAN DIFFERENCE BETWEEN SPO2 AND SAO2 IS IN ACCORDANCE WITH THE DISCREPANCY IN SPO2 MEASUREMENTS IN NEONATES FOUND IN ROSS ET AL. THE STANDARD DEVIATION OF THE TWO PULSE OXIMETERS WAS ABOVE 3%, SIMILAR TO THE STANDARD DEVIATION REPORTED FOR THE SPO2 DEVIATION FROM SAO2 IN NEONATES. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641082 ↗
• MalfunctionJan 31, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE GAVE SPO2 READINGS THAT WERE 10 POINTS LOW, USING DISPOSABLE FINGER PROBES. THE SENSORS AND CABLES WERE SWAPPED AND TRIED DIFFERENT MONITORS TO ISOLATE THE FAILURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613435 ↗
• InjuryFeb 26, 2021High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE SHOWN AN ERROR 11 AND HAD A READING OF 100% BUT THE BLOOD GAS REPORTED 75%. ANOTHER NEW MONITOR WAS USED AND HAVE THE SAME READING WITH THE BLOOD GAS REPORT WHICH IS 75%. THE PATIENT EXPERIENCE TACHYPNEA AND DIED THE NEXT DAY DUE TO COMPLICATIONS OF COVID. THE DEVICE WAS NOT CONTRIBUTED TO PATIENT'S DEATH.

  Patient problems: Respiratory Failure

  MAUDE report 11386458 ↗
• MalfunctionMar 18, 2020Manufacturing, Packaging or Shipping Problem; Noise, Audible; Manufacturing, Packaging or Shipping Problem; Noise, Audible

  ACCORDING TO THE REPORTER, THE UNIT WAS OUT OF THE BOX FAILURE. IT WAS INDICATED THAT THE SPEAKER WAS NOT WORKING AT ALL, NO TONE OR SOUNDS EMITTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9850088 ↗
• MalfunctionNov 15, 2017Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED REPORT THAT DURING SETUP, SATSECONDS FEATURE WAS NOT ALARMING WHEN CIRCLE FILLED. IT HAD A DELAY OF APPROXIMATELY 30 SECONDS. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7035711 ↗