rainbow® DCI® SpCO® SpMet® SpO2 Adult Reusable Sensor 2696Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00843997004855), received between Jan 20, 2017 and Dec 16, 2021 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (8 reports).
1 other recall cover devices cleared under the same FDA submission (K080238); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Incorrect Measurement8
- Sensing Intermittently6
Patient problems
- No Consequences Or Impact To Patient11
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED MEASUREMENT LOSS FROM THE SENSOR. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13023005 ↗MalfunctionAug 26, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE SENSOR WAS INACCURATE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12374737 ↗MalfunctionApr 6, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED INTERMITTENT OPERATION WITH THE SENSOR. NO PATIENT IMPACT OF CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9930535 ↗MalfunctionApr 6, 2018Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED: "INTERMITTENTLY LOSING SIGNAL.". NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7405543 ↗MalfunctionApr 6, 2018Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED: "INTERMITTENTLY LOSING SIGNAL." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7405542 ↗MalfunctionJan 28, 2018Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED: "INTERMITTENTLY LOSING SIGNAL." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7224037 ↗MalfunctionJan 28, 2018Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED: "INTERMITTENTLY LOSING SIGNAL." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7224036 ↗MalfunctionDec 1, 2017Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE SPCO SENSOR IS NOT READING PROPERLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7077548 ↗MalfunctionDec 1, 2017Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE SPCO SENSOR IS NOT READING PROPERLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7077547 ↗MalfunctionDec 1, 2017Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE SPCO SENSOR IS NOT READING PROPERLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7077546 ↗MalfunctionDec 1, 2017Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE SPCO SENSOR IS NOT READING PROPERLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7077545 ↗MalfunctionDec 1, 2017Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE SPCO SENSOR IS NOT READING PROPERLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7077543 ↗MalfunctionDec 1, 2017Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE SPCO SENSOR IS NOT READING PROPERLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7077542 ↗MalfunctionJan 20, 2017Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THERE WAS POOR READINGS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6268778 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K080238. One submission often covers many models, so check the product and lot details in each record.
- Z-0338-2016 · Oct 28, 2015 · Terminatedrainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW
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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