M-LNCS™ Neo SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor 2514Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10843997002568), received between Nov 7, 2016 and Nov 30, 2016 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (5 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.

• MalfunctionNov 30, 2016Incorrect Measurement; Device Sensing Problem; Incorrect Measurement; Device Sensing Problem

  THE CUSTOMER REPORTED FALSE READING, DROPPED SIGNALS, OR WEAK READINGS AND THAT THE PHOTO DETECTOR IS OUT OF THE WINDOW ON MANY OF THE SENSORS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6135642 ↗
• MalfunctionNov 30, 2016Incorrect Measurement; Device Sensing Problem; Incorrect Measurement; Device Sensing Problem

  THE CUSTOMER REPORTED FALSE READING, DROPPED SIGNALS, OR WEAK READINGS AND THAT THE PHOTO DETECTOR IS OUT OF THE WINDOW ON MANY OF THE SENSORS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6135630 ↗
• MalfunctionNov 30, 2016Incorrect Measurement; Device Sensing Problem; Incorrect Measurement; Device Sensing Problem

  THE CUSTOMER REPORTED FALSE READING, DROPPED SIGNALS, OR WEAK READINGS AND THAT THE PHOTO DETECTOR IS OUT OF THE WINDOW ON MANY OF THE SENSORS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6135624 ↗
• MalfunctionNov 7, 2016Incorrect Measurement; Device Stops Intermittently; Incorrect Measurement; Device Stops Intermittently

  THE CUSTOMER REPORTED FALSE READING, DROPPED SIGNALS, OR WEAK READINGS AND THAT THE PHOTO DETECTOR IS OUT OF THE WINDOW ON MANY OF THE SENSORS. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6081094 ↗
• MalfunctionNov 7, 2016Incorrect Measurement; Device Stops Intermittently; Incorrect Measurement; Device Stops Intermittently

  THE CUSTOMER REPORTED FALSE READING, DROPPED SIGNALS, OR WEAK READINGS AND THAT THE PHOTO DETECTOR IS OUT OF THE WINDOW ON MANY OF THE SENSORS. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6081048 ↗