Nellcor 10005941Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 10884521163454), received between Aug 11, 2017 and Sep 21, 2026 — classified as 3 deaths, 2 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (41 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 23, 2025Open, Classified

   Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting

   Z-2151-2025 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 128 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Incorrect Measurement

  Patient problems: Insufficient Information

  MAUDE report 50849216 ↗
• MalfunctionApr 7, 2026Device Alarm System

  IT WAS REPORTED THAT THE ALARMS ON THE DEVICE WERE DISABLED AUTOMATICALLY. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24808795 ↗
• MalfunctionMar 24, 2026Device Alarm System

  IT WAS REPORTED THAT THE MONITOR¿S ALARM DID NOT SOUND WHEN SATURATION WAS BELOW THE SET LIMIT. IT WAS UNKNOWN IF THERE WERE ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24682684 ↗
• MalfunctionMar 12, 2026Incorrect Measurement; Failure to Analyze Signal

  IT WAS REPORTED THAT THE PULSE OXIMETER DID NOT MATCH THE PATIENT'S BASELINE CONDITION, WAS SLOW TO RESPOND, AND DISPLAYED A SUDDEN DROP WITHOUT RECORDING THE CURVE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24577302 ↗
• MalfunctionMar 11, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE GAVE INCORRECT DATA. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24569643 ↗
• MalfunctionFeb 23, 2026Incorrect Measurement

  IT WAS REPORTED THAT INCORRECT READINGS WERE OBSERVED WITH THE DEVICE DESPITE CHANGING THE CABLE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24414055 ↗
• MalfunctionDec 16, 2025Device Alarm System; Image Display Error/Artifact; Failure to Analyze Signal; Insufficient Device Problem Information; Device Alarm System; Image Display Error/Artifact; Failure to Analyze Signal; Insufficient Device Problem Information

  DUPLICATE OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817798 ↗
• MalfunctionDec 9, 2025Image Display Error/Artifact; Incorrect Measurement; Image Display Error/Artifact; Incorrect Measurement

  IT WAS REPORTED THAT PRIOR TO USE, THE UNIT DID NOT MEASURE WELL AND GAVE ERROR 2004 AND 20010. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756736 ↗
• MalfunctionDec 8, 2025Incorrect Measurement; High Readings; Incorrect Measurement; High Readings

  IT WAS REPORTED THAT THE MONITOR READ ERRONEOUSLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751690 ↗
• MalfunctionNov 17, 2025False Alarm; Incorrect Measurement; False Alarm; Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE KEPT BEEPING AND DISPLAYED INCORRECT SATURATION. THE NUMERICAL VALUES OBTAINED WAS 98%, 85/MIN. THE PATIENT SKIN TONE WAS BRIGHT. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23573437 ↗
• MalfunctionNov 14, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE INCORRECTLY RECORDED THE OXYGEN SATURATION CURVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554833 ↗
• MalfunctionNov 12, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE EQUIPMENT DID NOT MEASURE WELL. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23534046 ↗
• MalfunctionOct 20, 2025Device Alarm System; Image Display Error/Artifact; Device Alarm System; Image Display Error/Artifact

  IT WAS REPORTED THAT PRIOR TO USE, THE MONITOR DISPLAYED ERROR EEE910 AND THE BATTERY WAS REPLACED AGAIN FIVE MONTHS AGO. THE AUDIBLE NOISE HAD DISAPPEARED, AND IT WAS ALLEGED TO BE DUE TO A VOLTAGE RELAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23342441 ↗
• MalfunctionSep 9, 2025Device Alarm System; Image Display Error/Artifact; Failure to Analyze Signal; Device Alarm System; Image Display Error/Artifact; Failure to Analyze Signal

  IT WAS REPORTED THAT THE UNIT HAD NO READINGS AND THE UNIT ALARM WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012392 ↗
• MalfunctionAug 5, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE ALARM FAILED TO TRIGGER FOR SOME LIMITS ON THE REFERENCED DEVICE. DURING FUNCTIONAL TESTING, IT WAS NOTICED THAT THERE WAS A VARIED DELAY IN THE TRIGGERING OF SOME ALARMS. WHILE WORKING THROUGH ALL THE PRE-PROGRAMMED PATIENT SELECTIONS (NEONATAL, PAEDIATRIC AND ADULT) THE ALARMS FUNCTIONED FOR SOME OF THE LIMITS BUT FOR OTHERS IT DID NOT REGISTER UNTIL A DELAYED AMOUNT OF TIME AFTER. USING CALIBRATED TEST EQUIPMENT, CHANGED THE INPUT OF THE PULSE RATE AND SPO2 READINGS, THE VALUES AT A MEDIAN LEVEL BETWEEN THE 2 LIMITS, RESPECTIVELY, THEN EITHER INCREASED/DECREASED THE VALUES TO THE ALARM LIMITS TO HEAR THE AUDIBLE TONE AND VISUAL ALARM SYMBOL. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 22719125 ↗
• MalfunctionJun 11, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING A CHECKUP, THE EQUIPMENT WAS NOT PRODUCING ANY SOUND. THE EQUIPMENT WAS TESTED AGAIN, AND IT WAS CONFIRMED THAT THERE WAS NO SOUND. IT WAS RESTARTED, AND THE VOLUME PARAMETERS WERE ADJUSTED, MAKING IT OPERATIONAL AGAIN. FOLLOWING THE WARNING, THERE WERE NO VISUAL OR AUDIBLE ALARMS. HOWEVER, AFTER RECONFIGURATION, THE ALARMS BECAME FUNCTIONAL, BUT THE EQUIPMENT RECONFIGURED ITSELF AGAIN. THE EQUIPMENT WAS CHANGED, AND THE PATIENT CONTINUED TO BE MONITORED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186223 ↗
• MalfunctionJun 10, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE DID NOT BEEP WHEN THE OXYGEN SATURATION FELL BELOW THE MARKED PARAMETERS. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22179520 ↗
• MalfunctionJun 10, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING A CHECKUP, THE EQUIPMENT WAS NOT PRODUCING ANY SOUND. THE EQUIPMENT WAS TESTED AGAIN, AND IT WAS VERIFIED THAT THERE WAS NO SOUND. IT WAS RESTARTED, AND THE VOLUME PARAMETERS WERE ADJUSTED, LEAVING IT OPERATIONAL AGAIN. HOWEVER, AFTER TWO WEEKS, ANOTHER COMPLAINT WAS RECEIVED ABOUT THE SAME ISSUE. FOLLOWING THE WARNING, THERE WERE NO VISUAL OR AUDIBLE ALARMS. HOWEVER, AFTER RECONFIGURATION, THE ALARMS BECAME FUNCTIONAL, BUT THE EQUIPMENT RECONFIGURED ITSELF AGAIN. THE EQUIPMENT WAS CHANGED, AND THE PATIENT CONTINUED TO BE MONITORED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177291 ↗
• MalfunctionJun 9, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT A DEVICE DID NOT REGISTER DATA AND HAD ISSUE AS DESCRIBED AS "NOT HAS CORRECT REGISTERED." IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22167816 ↗
• MalfunctionMay 21, 2025Incorrect Measurement; Component Missing; Incorrect Measurement; Component Missing

  IT WAS REPORTED THE MONITOR DID NOT CAPTURE CONSTANTS AND THE CABLE WAS NOT COMPLETE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

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

  MAUDE report 22061627 ↗
• MalfunctionApr 4, 2025High Readings; Insufficient Device Problem Information; High Readings; Insufficient Device Problem Information

  DUPLICATE OF (B)(4). IT WAS REPORTED THAT THE DEVICE REGISTERED A HIGHER VALUE, INDICATING AN ISSUE WITH HIGH READINGS IN OXIMETRY. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21775113 ↗
• MalfunctionMar 2, 2025Use of Device Problem; Temperature Problem; Use of Device Problem; Temperature Problem

  IT WAS REPORTED THAT THE UNIT HAD UNKNOWN FAILURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A BURNED POWER CARD.

  Patient problems: Insufficient Information

  MAUDE report 21501298 ↗
• MalfunctionFeb 24, 2025Erratic or Intermittent Display; High Readings; Erratic or Intermittent Display; High Readings

  IT WAS REPORTED THAT THE DEVICE RECORDED HIGHER VALUES THAN THE ACTUAL, RESULTING IN ERRATIC READINGS. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21444720 ↗
• MalfunctionFeb 18, 2025No Display/Image; Incorrect Measurement; Poor Quality Image; No Display/Image; Incorrect Measurement; Poor Quality Image

  IT WAS REPORTED THAT A DEVICE DID NOT CAPTURE MEASUREMENTS CORRECTLY. AND STRIPES APPEARED ON THE MONITOR SCREEN. THE MALFUNCTION WAS LOCATED BEFORE USE ON PATIENT, THE SCREEN WAS BLACK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403657 ↗
• MalfunctionFeb 13, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE'S ALARM WAS NOT WORKING WELL. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21375069 ↗