Nellcor MAXNRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884522042048), received between Jan 25, 2018 and Dec 5, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2022Temperature Problem; Patient Device Interaction Problem; Temperature Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, HE DEVICE WAS PLACED ON THE PATIENT¿S FEET OVERNIGHT. BLISTERS AND RED SPOTS WERE NOTICED ON THE PATIENT¿S FOOT THE FOLLOWING MORNING WHERE THE DEVICE WAS PLACED. THE DEVICE WAS ROTATED ONTO THE OTHER FOOT THE NEXT DAY. HOWEVER, BLISTERS AND SPOTS WERE NOTICED AGAIN ON THE OTHER FOOT WHERE THE DEVICE WAS PLACED. IT WAS REPORTED THAT THE BLISTERS LOOKED LIKE THEY COULD HAVE BEEN CAUSED BY HEAT. THE SKIN CONDITION WAS APPARENT IMMEDIATELY AFTER REMOVAL. A SELF-ADHESIVE BLACK MEDICAL TAPE (TO HELP DISPERSE THE HEAT) WAS USED OVER THE TOP OF THE DEVICE TO KEEP IT IN PLACE. THE DEVICE WAS NOT CHECKED DURING THE 8-12 HOURS WHEN THE DEVICE WAS PLACED ON THE PATIENT. THE SKIN OF THE PATIENT WAS NOT CLEANED BEFORE THE APPLICATION OF THE DEVICE. THE PATIENT WAS PLACED ON SUPINE POSITION AND HAD A LITTLE PRESSURE ON THE FOOT FROM SWADDLE. THE PATIENT HAS NO ALLERGIES.  THE BLISTERS WERE NOT GETTING WORSE; ONE OF THE BLISTERS HAD POPPED AND WAS RESOLVING.

  Patient problems: Inflammation; Skin Inflammation/ Irritation

  MAUDE report 15916735 ↗
• MalfunctionDec 1, 2022Temperature Problem; Patient Device Interaction Problem; Temperature Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS PLACED ON THE PATIENT¿S FEET OVERNIGHT. BLISTERS AND RED SPOTS WERE NOTICED ON THE PATIENT¿S FOOT THE FOLLOWING MORNING WHERE THE DEVICE WAS PLACED. THE DEVICE WAS ROTATED ONTO THE OTHER FOOT THE NEXT DAY. HOWEVER, BLISTERS AND SPOTS WERE NOTICED AGAIN ON THE OTHER FOOT WHERE THE DEVICE WAS PLACED. IT WAS REPORTED THAT THE BLISTERS LOOKED LIKE THEY COULD HAVE BEEN CAUSED BY HEAT. THE SKIN CONDITION WAS APPARENT IMMEDIATELY AFTER REMOVAL. A SELF-ADHESIVE BLACK MEDICAL TAPE (TO HELP DISPERSE THE HEAT) WAS USED OVER THE TOP OF THE DEVICE TO KEEP IT IN PLACE. THE DEVICE WAS NOT CHECKED DURING THE 8-12 HOURS WHEN THE DEVICE WAS PLACED ON THE PATIENT. THE SKIN OF THE PATIENT WAS NOT CLEANED BEFORE THE APPLICATION OF THE DEVICE. THE PATIENT WAS PLACED ON SUPINE POSITION AND HAD A LITTLE PRESSURE ON THE FOOT FROM SWADDLE. THE PATIENT HAS NO ALLERGIES. THE BLISTERS WERE NOT GETTING WORSE; ONE OF THE BLISTERS HAD POPPED AND WAS RESOLVING.

  Patient problems: Inflammation; Skin Inflammation/ Irritation

  MAUDE report 15896954 ↗
• MalfunctionJan 25, 2018Defective Component

  PATIENT NEEDED A NEW OXIMETER PROBE. A NEW PROBE WAS PLACED AND ATTACHED TO THE RECORDING CABLE. ONCE ATTACHED THE MONITOR READ THAT THE PROBE HAD A FAULTY SENSOR. THIS PROBE WAS REMOVED AND ANOTHER NEW ONE WAS APPLIED AND AGAIN IT READ THAT THE PROBE HAD A FAULTY SENSOR. THIS OCCURRED AGAIN 10 DAYS LATER WITH ANOTHER PATIENT. UNCERTAIN OF LOT NUMBER BUT RECORDED THE NUMBER OF THE SAME DEVICE THAT WAS NEXT IN THE PATIENT CART. MAY NOT BE THE CORRECT LOT NUMBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7218476 ↗