Nellcor D-YSRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 20884522042540), received between Feb 2, 2018 and Jun 2, 2025 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Low Readings” (12 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT READINGS WERE NOT ACCURATE ON THE SENSOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123579 ↗
• MalfunctionNov 11, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SENSOR GAVE INACCURATE READINGS USED ON ANOTHER BRAND'S VITAL SIGNS MONITOR. THE SENSOR WAS SWAPPED WITH ANOTHER ONE THAT PROVIDED CORRECT AND CONSISTENT READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652612 ↗
• MalfunctionNov 11, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD LOW READING. THE CUSTOMER SWAPPED OUT NEW SENSOR AND THE READING DISPLAYED AS EXPECTED. THE ISSUE WAS ISOLATED TO THE OLDER SENSOR CABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652585 ↗
• MalfunctionSep 12, 2024Failure to Read Input Signal; Low Readings; Delayed Program or Algorithm Execution; Failure to Read Input Signal; Low Readings; Delayed Program or Algorithm Execution

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR HAD A READING EVEN WHEN NOT ON THE PATIENT. THE PATIENT WITH A TRACHEOSTOMY AND A HIGH RISK OF DECANNULATION WAS HAVING SPO2 MONITORED USING THE EAR CLIP SENSOR. THE NURSE NOTED THAT THE SPO2 WAS LOW AT 86% AS THEY WALKED PAST THE BED SPACE AND THEN NOTICED THAT THE SENSOR WAS ON THE PILLOW NEXT TO THE PATIENT'S CHEEK BUT WAS STILL SHOWING A TRACE AND SPO2 OF 86%. LATER THAT DAY, THE EAR CLIP SENSOR WAS FOUND IN THE PATIENT'S HAND, AND IT WAS STILL PICKING UP A TRACE AND A READING. IT WAS TESTED ON A HANDHELD MONITOR; THE SENSOR WAS CLIPPED TO RECEIVE A READING, THEN HELD HAND OVER THE SENSOR TO SEE IF A READING WAS PICKED UP. AS SOON AS THE SENSOR WAS REMOVED, THE READING DROPPED OFF. HOWEVER, WHEN RUBBING THE PERIPHERAL PART OF THE SENSOR, THERE WAS A SLIGHT QUICK READING, WHICH SHOULD NOT HAPPEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199147 ↗
• MalfunctionOct 26, 2022Failure to Read Input Signal; Delayed Program or Algorithm Execution; Failure to Read Input Signal; Delayed Program or Algorithm Execution

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SENSOR WAS DELAYED IN SENSING/READING AND TOOK 3 TO 5 MINUTES TO PICK UP THE HEART BEAT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674869 ↗
• MalfunctionOct 26, 2022Failure to Read Input Signal; Delayed Program or Algorithm Execution; Failure to Read Input Signal; Delayed Program or Algorithm Execution

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SENSOR WAS DELAYED IN SENSING/READING AND TOOK 3 TO 5 MINUTES TO PICK UP THE HEART BEAT. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

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

  MAUDE report 15674738 ↗
• MalfunctionFeb 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED BURNS (POSSIBLE ULCERS PRESSURE) ON THE FEET OF A NEONATAL ICU PATIENT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11301710 ↗
• MalfunctionFeb 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED BURNS (POSSIBLE ULCERS PRESSURE) ON THE FEET OF A NEONATAL ICU PATIENT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11301684 ↗
• MalfunctionFeb 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED BURNS (POSSIBLE ULCERS PRESSURE) ON THE FEET OF A NEONATAL ICU PATIENT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11301678 ↗
• MalfunctionFeb 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED BURNS (POSSIBLE ULCERS PRESSURE) ON THE FEET OF A NEONATAL ICU PATIENT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11301672 ↗
• MalfunctionFeb 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED BURNS (POSSIBLE ULCERS) PRESSURE) ON THE FEET OF A NEONATAL ICU PATIENT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11300399 ↗
• MalfunctionJan 15, 2021Low Readings

  ACCORDING TO THE REPORTER, THE SPO2 HAD DIFFERENCE OF GREATER THAN 10 PERCENT. IT SHOWED LOW SPO2 READINGS. THE ISSUE WAS ISOLATED TO THE SENSOR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11176943 ↗
• MalfunctionOct 28, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, AFTER USING THE NEW SENSOR WITHIN 5 DAYS, THE PATIENT WAS COMPLAINING OF PAIN DUE TO SENSOR AND THIS WAS EVEN AFTER CHANGING IT REGULARLY AS INSTRUCTED ON THE USER GUIDE. THE PATIENT ALSO DEVELOPED BURN BLISTERS. TRIED MOVING THE SENSOR TO DIFFERENT PARTS OF THE PATIENT'S FEET, WHICH WOULD GIVE A MUCH LOWER (AND INACCURATE) READING IN THE HOPES PATIENT'S SKIN WOULD TOLERATE IT BETTER BUT TO NO AVAIL. ALONG WITH THE BURN MARKS, THE PATIENT WOULD ALSO BE LEFT WITH VERY DEEP PRESSURE MARKS/INDENTS. THE SENSOR HAS BEEN UNFORTUNATELY VERY POOR IN TERMS OF ACCURACY AND BURNS/PRESSURE SORES TO PATIENT'S FEET AND TOES.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 10752187 ↗
• MalfunctionMar 5, 2020Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD SYSTEM FAILURE ERRORS WITH BOTH CABLES SWITCHED BETWEEN MACHINES DESPITE BATTERY CHANGES. THE UNIT USUALLY HAD LOW READING RANGING 90'S, 90-93. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9792318 ↗
• MalfunctionMar 5, 2020Image Display Error/Artifact; Low Readings; Connection Problem; Image Display Error/Artifact; Low Readings; Connection Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD SYSTEM FAILURE ERRORS WITH BOTH CABLES SWITCHED BETWEEN MACHINES DESPITE BATTERY CHANGES. THE UNIT USUALLY HAD LOW READING RANGING 90'S, 90-93. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9792307 ↗
• MalfunctionJan 29, 2020Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD READ 5% LOWER THAN OTHERS. THE ISSUE WAS ISOLATED WITH OTHER DEVICE. THE CUSTOMER INDICATED NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9642315 ↗
• MalfunctionJan 20, 2020Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD READ 5% LOWER THAN OTHERS. THE ISSUE WAS ISOLATED WITH OTHER DEVICE. THE CUSTOMER INDICATED NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9606993 ↗
• MalfunctionJan 2, 2020Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR GAVE AN ERROR MESSAGE AND ONLY SHOWED SPO2 READING OF 80% WHILE WITH A NEW SENSOR, IT SHOWED 100% SPO2 READING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538825 ↗
• InjuryNov 1, 2019Failure to Sense; Contamination /Decontamination Problem; Failure to Sense; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE SENSOR WAS APPLIED ON THE LEFT EAR LOBE OF A POORLY PERFUSED PATIENT, AND WAS UNABLE TO OBTAIN OXIMETRY READING. THE PATIENT HAD A THREE UNSTAGEABLE PRESSURE INJURIES TO LEFT EAR LOBE. THE PATIENT DIED, BUT DID PASS WITH INJURY PRESENT ON LEFT EAR LOBE. IT WAS INDICATED THAT THE DEATH WAS NOT RELATED TO THE DEVICE.

  Patient problems: Death; Pressure Sore/Ulcer

  MAUDE report 9269447 ↗
• InjuryOct 18, 2019Image Display Error/Artifact; Incorrect, Inadequate or Imprecise Result or Readings; Image Display Error/Artifact; Incorrect, Inadequate or Imprecise Result or Readings

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS NOT WORKING WITH SYSTEM FAILURE 010. WHEN IT WAS ATTACHED TO THE DISPOSABLE SENSOR IT WORKED FINE. THE PATIENT WEAR THE DEVICE TO TRACK OXYGEN DESATURATION WHILE SLEEPING BUT INACCURATE READINGS RESULTED IN FAILING TO ALERT WHEN THE OXYGEN LEVELS WERE LOW.

  Patient problems: Low Oxygen Saturation

  MAUDE report 9210744 ↗
• MalfunctionSep 23, 2019Device Emits Odor; Device Emits Odor

  ACCORDING TO THE REPORTER, WHEN TESTING THE SENSOR, THEY FOUND THAT THE SENSOR WAS BURNED OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9107605 ↗
• MalfunctionApr 9, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD A LOW SPO2 READING. IT WAS STATED THAT THE SATURATION VALUES WERE DOWN TO -6% AT THE SAME MEASURING POINT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497648 ↗
• MalfunctionNov 26, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED BURN OR ULCERATION ON THE DOGS TONGUE. IT WAS STATED THAT THE UNIT WAS ON THE DOGS TONGUE AROUND 3 HOURS AND THE PART OF THE TONGUE COULD NOT BE SAVED.

  Patient problems: Burn(s)

  MAUDE report 8103012 ↗
• MalfunctionSep 26, 2018Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT GAVE LOW READINGS WITH PEDIATRIC SENSORS. THE CUSTOMER REPORTED THAT THE UNIT OFTEN TOOK 45-60 SECONDS OR MORE TO READ AND READINGS WERE LOW (92-93 WITH GOOD WAVEFORMS) WHEN THE SATURATION SHOULD BE 98-99. THIS LOW READINGS HAVE COME IN SEVERAL KIDS WITH NO REASON TO HAVE A LOW PULSE, I.E. WARM FEET, NO FEVERS AND NO RESPIRATORY ILLNESSES. IT WAS INDICATED THAT THERE WAS NO PATIENT OUTCOME ABNORMALITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7912174 ↗
• MalfunctionApr 27, 2018Device Alarm System; False Reading From Device Non-Compliance; Device Alarm System; False Reading From Device Non-Compliance

  ACCORDING TO THE REPORTER, THE DEVICE HAD AN ERRATIC SPO2 READING. IT WAS REPORTED THAT WHEN THE SENSOR WAS DISCONNECTED FROM THE PATIENT, THERE IS NO ALARM. CUSTOMER REPORTED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7468176 ↗

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.