Nellcor MAXFAST (UDI 10884521815360)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521815360), received between Jul 15, 2022 and Jul 1, 2026 — classified as 1 death, 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Incorrect Measurement

  IT WAS REPORTED THAT A PATIENT IN THE ICU WAS BEING MONITORED WITH A FOREHEAD SPO2 PROBE AND WAS TRANSPORTED TO THE ENDOSCOPY SUITE FOR A PROCEDURAL SEDATION AND ERCP PROCEDURE. DURING TRANSPORT, THROUGHOUT THE PROCEDURE, AND FOLLOWING THE PROCEDURE, THE SPO2 PROBE INTERMITTENTLY FAILED TO PROVIDE A RELIABLE READING. THE WAVEFORM WAS POOR AND DID NOT CORRELATE WITH THE ARTERIAL LINE READINGS. THE SIGNAL QUALITY WORSENED DURING AND AFTER THE PROCEDURE. DUE TO THE UNRELIABLE READINGS, THE PATIENT¿S OXYGENATION WAS ASSESSED USING CLINICAL SIGNS SUCH AS GUM COLOR AND CHEST RISE. A NASAL SPO2 PROBE AND CABLE WERE BROUGHT DURING TRANSPORT AND BRIEFLY TRIALED DURING THE PROCEDURE; HOWEVER, NO WAVEFORM OR NUMERIC READING WAS OBTAINED, AND THE DEVICE WAS NOT USED FURTHER. THROUGHOUT THE PROCEDURE THE PATIENT¿S BLOOD PRESSURE REMAINED ADEQUATE, WITH SYSTOLIC BLOOD PRESSURE RANGING BETWEEN 90 AND 110 MMHG, AND CENTRAL PERFUSION APPEARED SUFFICIENT. DURING TRANSPORT BACK TO THE ICU, THE FOREHEAD SPO2 PROBE DISPLAYED READINGS BETWEEN 83¿88% WITH A POOR WAVEFORM. AT THAT TIME THE PATIENT WAS OBSERVED TO BE CENTRALLY CYANOTIC. THE PATIENT CONTINUED BREATHING WITHOUT OBSERVED APNEA OR SNORING. A R

  Patient problems: Cyanosis; Low Oxygen Saturation

  MAUDE report 25675280 ↗
• MalfunctionJul 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED WOUNDS ON BOTH SIDES OF THE HEAD AT THE SENSOR SITE DURING USE OF THE SENSOR. THE PATIENT E XPERIENCED A SKIN REACTION AND SKIN BREAKDOWN AT THE SENSOR SITE, WITH ONE WOUND BEING MORE SERIOUS THAN THE OTHER. THE WOUNDS EVOLVED FROM SMALL TO MORE SERIOUS WITHIN APPROXIMATELY 12 HOURS OF USE. THE PATIENT WAS TREATED FOR WOUND AND SKIN INJURY AT THE SENSOR SITE AND WAS REPORTED TO BE RECOVERING.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 22529912 ↗
• MalfunctionFeb 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING O2 MONITORING, THE PATIENT DEVELOPED WOUNDS, LIKELY BURNS, ON THE FOREHEAD FROM THE SENSOR. NO SEVERE HARM WAS REPORTED; HOWEVER, IT CAUSED SOME INCONVENIENCE TO THE PATIENT AND A RISK OF INFECTION OR SCARRING.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21354291 ↗
• MalfunctionMay 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE SENSOR CAUSED PRESSURE INJURY ON PATIENT'S FOREHEAD.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19248880 ↗
• MalfunctionApr 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT SUSTAINED LOOK-LIKE BURNS TO THE FOREHEAD FROM THE PROBE MONITOR. THE POSITION OF THE PATIENT WAS SUPINE OR LIKELY TURNED TO THE SIDE. THE WOUND WAS NOT A STAGEABLE WOUND AS IT WAS MORE OF A BURN THAN A PRESSURE INJURY. THE SENSOR WAS MOVED REGULARLY BY NURSING OR RRT. THE WOUND WAS LEFT OPEN TO THE AIR TO HEAL ON ITS OWN.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19127001 ↗
• DeathMay 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PATIENT HAD IDENTIFIED MARKS ON THE FOREHEAD FROM WHERE THE SENSOR HAD BEEN. THE PATIENT DIED. ADDITIONAL INFORMATION RECEIVED FROM THE REPORTING INTENSIVE CARE UNIT (ICU) IS THAT THEY BELIEVE THE INCIDENT WAS DUE TO USER ERROR, AND THAT THE PATIENT DEATH WAS NOT RELATED TO THE PULSE OXIMETER AS THE PATIENT HAD MULTIPLE FATAL COMORBIDITIES AT THE TIME.

  Patient problems: Insufficient Information

  MAUDE report 16933317 ↗
• MalfunctionJul 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE SENSOR "HEADBAND" WAS NOT USED. THEY RELOCATED THE SENSOR AFTER 30 MINUTES AND PATIENT WAS STILL GETTING SORES.

  Patient problems: Inflammation

  MAUDE report 15028345 ↗

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.