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Nellcor SC-NEORecalls & reported problems

Covidien LP · Neonatal SpO2 Sensor Non-Adhesive · Class 2

Adverse event reports
1
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884522042434), received between May 2, 2018 and May 2, 2018 — classified as 1 death.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • Death1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • DeathMay 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    A CUSTOMER CONTACTED US REGARDING A PRODUCT, PULSE OX (OXIMETER) BEDSIDE MONITOR. THE CUSTOMER FOUND THEIR INFANT CHILD UNRESPONSIVE. THE INFANT WAS LATER PRONOUNCED DECEASED BY MEDICAL PROFESSIONALS. THE INFANT WAS CONNECTED TO A PULSE OXIMETER WITH A SENSOR. THERE WERE NO ERROR CODES DISPLAYED ON THE MONITOR. THE PATIENT WAS ALSO CONNECTED TO A VENTILATOR. THE LOT NUMBER OF THE SENSOR WAS NOT RECORDED AND WILL NOT BE RETURNED. THE MONITOR HAS BEEN SENT BACK TO THE SERVICE CENTER IN (B)(4) FOR FAILURE INVESTIGATION.

    Patient problems: Death

    MAUDE report 7479158 ↗

Other Oximeter devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.