Nellcor MAXFASTI (UDI 20884522039694)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20884522039694), received between Feb 1, 2019 and Mar 7, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT WAS USED ON THE FOREHEAD OF A CRITICALLY ILL PATIENT. THE NODES ON THE PRODUCT'S ADHESIVE PROBE CAUSED PRESSURE INJURIES TO THE FOREHEAD. WOUND WAS TREATED WITH SALINE AND DRESSINGS. THE PATIENT WAS PALLIATED SHORTLY AFTER AND DECEASED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 13684533 ↗
• MalfunctionMar 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT WAS USED ON THE FOREHEAD OF A CRITICALLY ILL PATIENT. THE NODES ON THE PRODUCT'S ADHESIVE PROBE CAUSED PRESSURE INJURIES TO THE FOREHEAD. WOUND WAS TREATED WITH SALINE AND DRESSINGS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 13626854 ↗
• MalfunctionFeb 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT WAS USED ON THE FOREHEAD OF A CRITICALLY ILL PATIENT. THE NODES ON THE PRODUCT'S ADHESIVE PROBE CAUSED PRESSURE INJURIES TO THE FOREHEAD.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 13418839 ↗
• InjuryDec 29, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE PRODUCT CAUSED A PRESSURE INJURY FROM THE BAND TENSION. ON DAY 11, A STAGE TWO PRESSURE SORE WAS DISCOVERED UNDER THE BAND AND RAPIDLY DEVELOPED A STAGE THREE PRESSURE SORE ON THE OCCIPITAL AREA. IT WAS REPORTED THAT A DEBRIDEMENT WAS NECESSARY. THERE WAS A SUBSEQUENT DISCHARGE FROM THE INTENSIVE CARE UNIT AND PLASTIC SURGERY WAS CONSIDERED BUT THE SORE WAS APPARENTLY HEALING WELL, AND PLASTIC SURGERY DEEMED UNNECESSARY. IT WAS INDICATED THAT A BALD PATCH WAS LEFT WHERE A DEVICE BAND WAS AND HAD NO HAIR REGROWTH. THE PATIENT HAD A MEDICAL HISTORY OF HEAD TRAUMA WITH THE PRESENCE OF EDEMA AND WAS DIAGNOSED WITH SEPTIC SHOCK 10 DAYS BEFORE THE DECUBITUS ULCER FORMATION.

  Patient problems: Pressure Sore/Ulcer; Septic Shock

  MAUDE report 11087689 ↗
• MalfunctionNov 26, 2019Contamination /Decontamination Problem; Material Integrity Problem; Contamination /Decontamination Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR WAS CONNECTED TO THE PATIENT'S FOREHEAD AND WHEN THEY SHIFTED THE PLACE OF THE SENSOR, THEY FOUND A BRUISE OVER THE PLACE THEY HAD CONNECTED THE SENSOR. THE PATIENT'S FOREHEAD GOT WOUND. THE DEVICE HAD PHYSICAL DAMAGE.

  Patient problems: Bruise/Contusion

  MAUDE report 9379786 ↗
• MalfunctionJul 19, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SENSORS HAD LEFT A SMALL BURNT MARK ON A PATIENT'S FOREHEAD. THE SENSOR WAS ON FOR 8 TO 10 HOURS. THE BANDAGE WAS NOT USED AS THE PATIENT NEEDED TO WEAR A FULL FACE OXYGEN MASK THROUGHOUT THE NIGHT.

  Patient problems: Burn(s)

  MAUDE report 8808461 ↗
• MalfunctionApr 24, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE DEVICE MADE A MARK ON PATIENT FOREHEAD.

  Patient problems: Injury

  MAUDE report 8544463 ↗
• MalfunctionFeb 1, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THERE WAS AN IMPRESSION ON THE PATIENT'S SKIN UNDERNEATH THE SENSOR. IT WAS ALSO REPORTED THAT THIS OCCURRED FOR MORE THAN ONE PATIENT.

  Patient problems: Skin Irritation

  MAUDE report 8296455 ↗

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.