Nellcor SC-PR-IRecalls & reported problems
Covidien LP · Preemie SpO2 Sensor Non-Adhesive;OxiMax (TM) Technology · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 10884522042833), received between Jan 12, 2021 and Jan 12, 2021 — classified as 1 death.
The most frequently reported specific device problem is “High Readings” (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
- High Readings1
Patient problems
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 12, 2021High Readings; High Readings
ACCORDING TO THE REPORTER, ON (B)(6) 2020, THERE WAS AN ERROR WITH BLOOD OXYGEN MEASUREMENT IN THE MONITORING OF PREMATURE INFANT. THE MACHINE SHOWED THAT SPO2 WAS 100%, BUT THE PATIENT THERE WAS HYPOXIA, AND BLOOD GAS ANALYSIS SHOWED ONLY 24%. THE PATIENT DIED ON (B)(6) 2020.
Patient problems: Low Oxygen Saturation
MAUDE report 11155152 ↗
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- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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