MasimoSET® LNCS® DBI SpO2 Adult Soft Reusable Sensor 2653Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00843997003094), received between Sep 5, 2017 and Dec 2, 2022 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Sensing Intermittently” (9 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 Intermittently9
- Low Readings2
- Device Stops Intermittently1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SENSOR WAS TESTED AND THE RESULTS WERE INTERMITTENT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15909268 ↗MalfunctionJul 8, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE NO LONGER "CONDUCTS" AFTER A SHORT TIME IN OPERATION. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14961688 ↗MalfunctionNov 6, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SENSOR REPEATEDLY HAS SIGNAL BREAKS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12755883 ↗MalfunctionOct 7, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED SIGNAL INTERRUPTIONS TO THE DEVICE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12595088 ↗MalfunctionMay 6, 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 11787613 ↗MalfunctionMay 6, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SENSOR LOSES VALUES SPORADICALLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11787347 ↗MalfunctionJun 1, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE DB-I SENSOR WAS WORKING INTERMITTENTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10105483 ↗MalfunctionSep 27, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED "INTERMITTENT FAULT." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9130338 ↗MalfunctionMar 25, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED READING IS VERY LOW ON RAD-5 AND SHOWING CHECK SENSOR. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8450265 ↗MalfunctionMar 25, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED READING IS VERY LOW ON RAD-5 AND SHOWING CHECK SENSOR. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8450264 ↗MalfunctionMar 2, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE "SENSOR IS PRESENTING AN INTERMITTENT READING." NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8384324 ↗MalfunctionSep 5, 2017Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED THIS WILL ONLY READ INTERMITTENTLY. CUSTOMER HAS ALREADY USED OTHER CABLES, BUT WITH SAME RESULT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6842205 ↗
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- 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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