MasimoSET® Red DCI-dc3 SpO2 Adult Reusable Sensor 2053Recalls & reported problems
Masimo Corporation · MasimoSET Red DCI-dc3 SpO2 Adult Reusable Sensor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843997001236), received between Feb 24, 2017 and Feb 21, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (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 18, 2026.
Most reported problems
Device problems
- Inappropriate or Unexpected Reset1
- Incorrect Measurement1
- Loose or Intermittent Connection1
- Sensing Intermittently1
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SENSOR WAS WORKING INTERMITTENTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8360408 ↗MalfunctionOct 12, 2018Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED: "ACCORDING TO CUSTOMER, THE SENSOR SUDDENLY STOPPED WORKING. TESTED AT (B)(6) WITH THE SAME RESULT. NOT RELIABLE." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7962405 ↗MalfunctionJan 18, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
THE CUSTOMER REPORTED THAT THE SENSOR DOES NOT READ SPO2 CONSISTENTLY AND THE WIRES ATTACHED TO FINGER PART ARE FRAYED. ADDITIONAL INFORMATION INDICATED THE PRODUCT WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES. THE PRODUCT WOULD WORK IF THE LEAD WAS JIGGLED SOMETIMES, BUT SOMETIMES NOT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7203130 ↗MalfunctionFeb 24, 2017Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE CUSTOMER USES "CARDIOSAT 100" SIMULATOR. THE CUSTOMER STATES THAT WHEN THEY SET THE SIMULATOR TO 98% SPO2 AND 60 BPM. AT THIS SETTING THE SENSOR READS 92% SPO2 AND 60 BPM. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6356605 ↗
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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 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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