RD SET 4054Recalls & reported problems
Masimo Corporation · YI Multisite Pulse Oximeter Reusable Sensor · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00843997013079), received between Mar 29, 2021 and Nov 4, 2022 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Sensing Intermittently” (10 reports).
1 other recall cover devices cleared under the same FDA submission (K180046); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Sensing Intermittently10
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED INTERMITTENT FAULT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15736227 ↗MalfunctionSep 24, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED "SENSOR BLINKING PROBLEM INTERMITTENTLY." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15477964 ↗MalfunctionSep 2, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED "SENSOR BLINKING PROBLEM INTERMITTENTLY." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15352607 ↗MalfunctionAug 25, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SENSOR WAS INTERMITTENT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15298872 ↗MalfunctionJun 17, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED: "FAULTY, INTERMITTENT LIGHT". NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14738602 ↗MalfunctionMar 16, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED AN INTERMITTENT SENSOR. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13778600 ↗MalfunctionMar 16, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED AN INTERMITTENT SENSOR. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13778598 ↗MalfunctionFeb 1, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SENSOR WAS IN USE AND STOPPED WORKING FOR NO REASON. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13416204 ↗MalfunctionNov 11, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED TEN (10) SENSORS EITHER HAD NO LIGHT DETECTED, INTERMITTENT LIGHT, OR NO TRACE DETECTED WHEN IN USE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12799901 ↗MalfunctionMar 29, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SENSOR HAD INTERMITTENT PROBLEMS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11584731 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K180046. One submission often covers many models, so check the product and lot details in each record.
- Z-1983-2023 · Apr 21, 2023 · Open, ClassifiedMasimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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