MasimoSET® M-LNCS™ DBI SpO2 Adult Soft Reusable Sensor 2507Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843997003698), received between Aug 28, 2017 and Oct 15, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Sensing Intermittently” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Sensing Intermittently2
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SENSOR SPORADICALLY SHOWS NO VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12643156 ↗MalfunctionApr 30, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SENSOR SPORADICALLY SHOWS NO VALUES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11754196 ↗MalfunctionAug 28, 2017Loose or Intermittent Connection; Loose or Intermittent Connection
THE CUSTOMER REPORTED A LOOSE CONNECTION. THE COLLEAGUES FROM OUR CUSTOMER SERVICE INDICATED THIS ERROR AS ¿DEFECTIVE CONNECTION". THAT'S WHY THE CONNECTION IS INTERRUPTED FROM TIME TO TIME. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6823314 ↗
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- 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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