Nellcor DS100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521129474), received between May 22, 2018 and Nov 12, 2024 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Low Readings” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE VALUE OF THE SENSOR WAS NOT UP TO STANDARD PRIOR TO USE. THE STANDARD VALUE WAS 100%, BUT THE ACTUAL MEASUREMENT WAS 80%. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664281 ↗
• MalfunctionFeb 5, 2024Incorrect Measurement; Device Damaged Prior to Use; Incorrect Measurement; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD INACCURATE READINGS AND NOT KNOWN IF IT WAS LOW OR HIGH. THE DEVICE WAS ALSO FOUND CRACKED AND BROKEN. THE SENSOR WAS REMOVED FROM CLINICAL USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18646285 ↗
• MalfunctionJul 26, 2023Image Display Error/Artifact; Low Readings; Image Display Error/Artifact; Low Readings

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE WAS GIVING A SYSTEM ERROR MESSAGE AND A LOW SPO2 READING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401636 ↗
• MalfunctionApr 5, 2023Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE SENSOR HAD SPO2 LOW VALUES WHEN PATIENTS CAME OFF OF PERFUSION PUMP DURING HEART SURGERY. THE USER STATED THAT THE SPO2 VALUES DID NOT CORRELATE AT ALL WITH THE ARTERIAL BLOOD GAS READING. IT WAS REPORTED THAT THE EXPECTED RANGE WAS PAO2 = 300MMHG INDICATING SPO2 OFN 98-100%. THE SPO2 READING MEASURED 80%. THE OPERATING TEMPERATURE WAS THE STANDARD ROOM TEMPERATURE AND THE PATIENT BODY TEMPERATURE WAS 34-36 CELSIUS. THERE WAS NO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685860 ↗
• MalfunctionApr 5, 2023Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE SENSOR HAD SPO2 LOW VALUES WHEN PATIENTS CAME OFF OF PERFUSION PUMP DURING HEART SURGERY. THE USER STATED THAT THE SPO2 VALUES DID NOT CORRELATE AT ALL WITH THE ARTERIAL BLOOD GAS READING. IT WAS REPORTED THAT THE EXPECTED RANGE WAS PAO2 = 300MMHG INDICATING SPO2 OFN 98-100%. THE SPO2 READING MEASURED 80%. THE OPERATING TEMPERATURE WAS THE STANDARD ROOM TEMPERATURE AND THE PATIENT BODY TEMPERATURE WAS 34-36 CELSIUS. THERE WAS NO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685780 ↗
• MalfunctionDec 9, 2021Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT READINGS WITH THESE SENSORS INDUCED GLITCHES IN THE DATA SET AFTER DOWNLOADING WITH NAT. UNIT WAS USED ON 5 MINUTE WALK TESTS, EVERY PATIENT. BATTERY COIN CELL WAS REPLACED. DROP-OUTS WERE EXPERIENCED DURING USAGE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967817 ↗
• MalfunctionDec 8, 2020Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE READING WAS TOO LOW THAN NORMAL. THE SENSOR WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10968958 ↗
• MalfunctionFeb 26, 2020Low Readings; Low Readings

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE UNIT HAD NO SPO2 READING INITIALLY. WHEN THE UNIT WAS TESTED WITH STIMULATORS, THE SPO2 READING WOULD DROP TO 7X% BUT WHEN IT WAS REPLACED WITH A NEW SENSOR, THE READING OF THE PATIENT WAS 9X% IN THE NORMAL RANGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9753194 ↗
• MalfunctionJan 6, 2020Low Readings; Low Readings

  ACCORDING TO THE REPORTER, ON SEVERAL OCCASIONS AND WITH SEVERAL SENSORS OF THE SAME MODEL THE LATTER WENT INTO THE DEFECTIVE SENSOR, ALARM ON THE SCOPES AND AFTER ABOUT TEN SECONDS OF USE AND DESPITE SEVERAL ATTEMPTS TO CHANGE THE CABLES. IT WAS INDICATED THAT VALUES WERE VERY LOW NOT CORRELATED WITH THE PATIENT STATE. THE PROBLEM CAME FROM CLEANING WHICH LEFT A FILM ON THE SENSOR AND DISTURBED THE SIGNAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9551135 ↗
• MalfunctionDec 27, 2019Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE DEVICE COULD NOT SHOW THE READINGS CORRECTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9525847 ↗
• MalfunctionDec 8, 2019Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE DEVICE BRUSHED THE BACK OF THE USER¿S HAND CAUSING A SMALL ELECTRICAL SHOCK WHICH CAUSED REDDENING OF THE AFFECTED AREA ON THE USER¿S HAND. IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OR REPRODUCE THE ELECTRIC SHOCK. NO ANOMALIES WERE OBSERVED IN THE USE OF THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT.

  Patient problems: Skin Irritation

  MAUDE report 9435189 ↗
• MalfunctionDec 4, 2019High Readings; High Readings

  ACCORDING TO THE REPORTER, THE UNIT GAVE AN ERRATIC PULSE RATE. IT WAS INDICATED THAT HEART RATE READINGS WERE FROM 178-181 AND A STILL PHOTO SHOWED A HEART RATE AT 223. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 9410903 ↗
• MalfunctionAug 2, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE DEVICE TOOK LONGER THAN NORMAL TO GIVE BLOOD PRESSURE AND ALSO GIVING LOW OXYGEN SAT NUMBERS ON MOST PEOPLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8855990 ↗
• MalfunctionJul 19, 2018Patient-Device Incompatibility; Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE SENSOR CAUSED WOUNDS.

  Patient problems: Injury; Skin Irritation

  MAUDE report 7702153 ↗
• InjuryMay 22, 2018Failure to Sense; Failure to Sense

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE STOPPED PROVIDING READING OF SPO2 (PERIPHERAL CAPILLARY OXYGEN SATURATION) VALUE. IT WAS STATED THAT THE NURSE CHECKED THE PART WHERE THE SENSOR WAS APPLIED AND CONFIRMED BLEEDING ON THE EDGE OF THE PATIENT'S NAIL.

  Patient problems: Injury

  MAUDE report 7534719 ↗

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.