Nellcor OxySoft OxySoftNJRecalls & reported problems
Covidien LP · Neonatal-Adult SpO2 Sensor;OxiMax (TM) Technology · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521818989), received between May 7, 2025 and May 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction 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.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT, DURING USE, AN INFANT ADMITTED TO THE NICU WHO WAS BORN WEIGHING JUST UNDER 2,400G HAD EXPERIENCED SKIN DAMAGE AND DETACHMENT ON THE THIRD DAY. THE DAMAGE HAD CORRESPONDED TO THE SENSOR'S LIGHT-EMITTING PART. THE IMAGE HAD SHOWN THE LOWEST DAMAGED PART AMONG THE THREE PARTS ON THE RIGHT FOOT. THERE HAD ALSO BEEN PRESSURE SORES DUE TO PRESSURE, BUT THE SITUATION WAS IDENTIFIED AS BURNS.
Patient problems: Burn(s)
MAUDE report 21977266 ↗
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.