RD SET™ NeoPt SpO2, PR, PI, PVI® Neonatal Pulse Oximeter Adhesive Sensor 4004Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10843997009604), received between May 27, 2017 and May 3, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Stops Intermittently” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2019Low Readings; Low Readings

  THE CUSTOMER REPORTED INACCURATE LOW SPO2 READING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8580164 ↗
• MalfunctionFeb 2, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE SPO2 VALUE IS NOT STABLE AND THE PR VALUE IS ALSO NOT STABLE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7238501 ↗
• MalfunctionDec 1, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED THAT THE SENSORS STOP WORKING. SOMETIMES THEY LAST ONLY 1 HOUR AND SOMETIMES 24 HOURS. NO ERROR CODE WAS GIVEN. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7077555 ↗
• MalfunctionSep 3, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED THE VALUE WAS CAME UP AND OFF. CLARIFICATION WAS OBTAINED FROM THE CUSTOMER REGARDING THE REPORT: "THE VALUE WAS RECEIVED ON THE MONITOR AND THEN SUDDENLY DISPLAY NO VALUES." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6840673 ↗
• MalfunctionMay 27, 2017Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT A DESATURATION WAS NOTED BY MASIMO CLINICAL SPECIALIST WHILE DISCUSSING TROUBLESHOOTING WITH RN. THE PATIENT APPEARED PINK AND NOT IN ANY DISTRESS WHILE IN BED. SENSOR APPLIED ACCORDING TO THE DFUS TO THE BABY'S LEFT FOOT. DURING THE TIME OF THE DESAT, THE PR REMAINED THE SAME (MATCHING WITH ECG) (GE MONITOR IN USE 12 SEC AVG TIME, NORMAL SENSITIVITY). THE PLETH WAS COMPLETELY FULL OF ARTIFACT. SPO2 DECREASED TO 83%, THEN BACK UP TO 100% WITHIN 3 SECONDS. THE SAME EXACT EVENT REOCCURRED LESS THAN 2 MINUTES LATER. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6596238 ↗