Nellcor DOC10Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884522042468), received between Apr 11, 2019 and Dec 30, 2025 — classified as 1 death, 12 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT THE SENSOR CONNECTION CABLE AND SENSOR PRODUCED LOW SPO2 READINGS. THE VALUES RANGED FROM 88 TO 92%, ALTHOUGH READINGS WERE EXPECTED TO BE ABOVE 95%. THE SENSOR WAS USED DURING A DENTAL PROCEDURE IN A SEPARATE ROOM WITH NO WINDOWS, AND IT WAS NOT COVERED. NO ERROR MESSAGE APPEARED, ONLY AN ALARM INDICATED LOW SPO2 READINGS. THE PATIENT WAS AN ANIMAL CONNECTED TO AN ECG AND A BLOOD PRESSURE CUFF AND PLACED ON A WARMING PAD, BUT THE SENSOR WAS ALSO TESTED ON A HUMAN, WHICH ALSO PRODUCED LOW READINGS. WHEN ANOTHER BRAND WAS USED, RESULTS RANGED FROM 97 TO 100%. NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921926 ↗
• DeathNov 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT WAS FOUND UNRESPONSIVE WITH A SENSOR PLACED ON THE BED SHEET INSTEAD OF THE PATIENT. THE MONITOR STILL SHOWED A HEART RATE OF 128 AND AN O2 SATURATION OF 98%. RESUSCITATION WAS PERFORMED, BUT THE PATIENT PASSED AWAY. WHILE REVIEWING THE LOGS, IT APPEARED THAT THE MALFUNCTION DID NOT ORIGINATE FROM THE SENSOR OR CABLE, AND IN THE ALARM LOGS, THE ALARMS WERE ALARMING.

  Patient problems: Insufficient Information

  MAUDE report 20724517 ↗
• MalfunctionNov 12, 2024Delayed Program or Algorithm Execution; Delayed Program or Algorithm Execution

  ACCORDING TO THE REPORTER, THE PATIENT WAS FOUND UNRESPONSIVE WITH A SENSOR PLACED ON THE BED SHEET INSTEAD OF THE PATIENT. THE MONITOR STILL SHOWED A HEART RATE OF 128 AND AN O2 SATURATION OF 98%. THE PATIENT PASSED AWAY, BUT IT IS UNKNOWN IF THE DEVICE FAILURE CONTRIBUTED TO THE DEATH.

  Patient problems: Insufficient Information

  MAUDE report 20662583 ↗
• MalfunctionSep 12, 2024High Readings; Low Readings; High Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE MONITOR SHOWED INCREDIBLY LOW READINGS. THE SPO2 READING WAS AT 70%, AND THE HEART RATE (HR) WAS AT 200 BPM, INDICATING POTENTIAL CARDIAC ARREST. THE EMERGENCY MEDICAL TECHNICIANS (EMTS) ARRIVED AND FOUND THAT THE PATIENT WAS FINE. THE RESPONDER'S OXIMETER WAS USED ON THE PATIENT, AND IT READS SPO2 99% AND HR 140 BPM. MULTIPLE PROBES WERE USED, AND THE READINGS WOULD FREQUENTLY GO TO 0'S AND THEN BACK UP. THE FAILURE WAS ALLEGEDLY ISOLATED FROM THE MONITOR BY SWAPPING THE SENSORS. THERE WAS NO ERROR CODE NOTED, AND AN ADHESIVE WAS USED TO HOLD THE SENSOR IN PLACE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206584 ↗
• MalfunctionFeb 6, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE CABLE HAD A VERY LOW OXYGEN READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18652781 ↗
• MalfunctionMay 25, 2021Image Display Error/Artifact; Communication or Transmission Problem; Image Display Error/Artifact; Communication or Transmission Problem

  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 11874208 ↗
• MalfunctionMar 10, 2020Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD FALSE/UNRELIABLE READING OF THE SPO2 AND THE PLETH. THEY REPLACED THE SENSOR WITH A NEW CABLE, BUT THE ISSUE WAS REMAINING INADEQUATE READING. IT WAS NEVER CLEAR WHEN EXACTLY THE FALSE VALUE DID APPEAR. IT WAS ON SEVERAL DIFFERENT CHILDREN WITH DIFFERENT CONDITIONS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9814038 ↗
• MalfunctionAug 29, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CAUSED A TONGUE ULCER TO THE PATIENT.

  Patient problems: Ulcer

  MAUDE report 8946105 ↗
• MalfunctionJun 26, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE SENSOR CAUSED A LOW TEMPERATURE TO BURN ON AN ANIMAL. THE CUSTOMER REPORTED THAT THE TONGUE HAD DISCOLORED TO WHITE AT 2 SITES, CENTER AND END. AFTER THAT, THE END SITE HAD ABSENCE WHICH SEEMS THE OCCURRENCE OF LOW TEMPERATURE HARM HAD SWELLED.

  Patient problems: Burn(s)

  MAUDE report 8738077 ↗
• MalfunctionApr 11, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED AN ULCER TONGUE LACERATION TO AN ANIMAL.

  Patient problems: Laceration(s)

  MAUDE report 8505799 ↗
• MalfunctionApr 11, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED AN ULCER TONGUE LACERATION TO AN ANIMAL.

  Patient problems: Laceration(s)

  MAUDE report 8505786 ↗
• MalfunctionApr 11, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED AN ULCER TONGUE LACERATION TO AN ANIMAL.

  Patient problems: Laceration(s)

  MAUDE report 8505748 ↗
• MalfunctionApr 11, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE CAUSED AN ULCER TONGUE LACERATION TO AN ANIMAL.

  Patient problems: Laceration(s)

  MAUDE report 8503663 ↗

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.