LNCS 3858Recalls & reported problems
Masimo Corporation · LNCS TFA-1 Adult/Pediatric Disposable Transflectance Sensor · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10843997008867), received between Dec 20, 2017 and Jan 5, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
- Patient-Device Incompatibility1
Patient problems
- Burn(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
PER MEDWATCH REPORT: STAFF NOTICED A TREND IN THE MASIMO PULSE OX NOT BEING ACCURATE, POSSIBLY RELATED TO DISPOSABLE SENSOR ISSUES. THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18456622 ↗InjuryDec 20, 2017Patient-Device Incompatibility; Patient-Device Incompatibility
THE CUSTOMER REPORTED A PATIENT WAS BURNED FROM HIS PULSE OX ON HIS RIGHT HAND THE PATIENTS MOTHER NOTICED IT AFTER SHE REMOVED IT FOR HIS BATH.
Patient problems: Burn(s)
MAUDE report 7135963 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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