Nellcor 10076644Recalls & reported problems
Covidien LP · SpO2 Module,Interface Cable included,For use with Philips IntelliVue Patient Monitors. · 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 10884521139619), received between Aug 4, 2025 and Aug 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Alarm System” (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
- Device Alarm System1
- Low Readings1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2025Device Alarm System; Low Readings; Device Alarm System; Low Readings
IT WAS REPORTED THAT THE DEVICE HAD AN ISSUE, WHICH WAS SET TO "HOME CARE MODE," FAILING TO ALERT THEM OF THEIR SON'S OXYGEN LEVEL DROPS. DUE TO THIS CRITICAL FAILURE, THE CUSTOMER SWITCHED TO ANOTHER BRAND FOR RELIABILITY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 22708218 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.