Nellcor MAX-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10817357020011), received between Nov 30, 2023 and Dec 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT HAD PRESSURE ULCER WHILE USING THE SENSOR. THE PATIENT'S HAND WERE SWOLLEN AFTER USING THE DEVICE.

  Patient problems: Ulcer

  MAUDE report 18339204 ↗
• MalfunctionNov 30, 2023Incorrect Measurement; Failure to Analyze Signal; Communication or Transmission Problem; Incorrect Measurement; Failure to Analyze Signal; Communication or Transmission Problem

  ACCORDING TO THE REPORTER, THE SENSOR HAD NO SPO2 READINGS OR SIGNAL ACQUISITION. WHEN USED ON A PATIENT, A READING OF 100% WAS COMING AND GOING AND IT HAD A NOTICEABLE INTERFERENCE IN TRACE. A WRAP WAS USED TO SECURE IT ON PATIENT'S FINGER AND SITE WAS CHECKED EVERY 4 HOURS. THE SAME SENSOR WAS PLUGGED IN A DIFFERENT MONITOR AND GOT SOLID READING OF 90%, HOWEVER WAVEFORM WAS NOT VERY CLEAN. ANOTHER SENSOR WAS PLUGGED INTO DIFFERENT MODULE AND HAD SAME RESULT AS BEFORE OF NOISY TRACE AND INTERMITTENT INCORRECT READING. THE MODULE WAS REMOVED FROM THE MAIN MONITOR AND PLUGGED INTO A PORTABLE MONITOR RUNNING IN BATTERY WITH SAME RESULT. THE REPORTED SENSOR WAS COVERED WITH TOWEL AND THE WAVEFORM IMPROVED AND CORRECT SPO2 READING WAS OBTAINED. THE TOWEL COVERING THE SENSOR WAS THEN REMOVED AND WAVEFORM HAD GOOD QUALITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239154 ↗