rainbow® DCI-dc3 SpCO® SpMet® SpO2 Adult Direct Connect Reusable Sensor 2201Recalls & reported problems
Masimo Corporation · rainbow DCI-dc3 SpCO SpMet SpO2 Adult Direct Connect Reusable Sensor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843997001663), received between Nov 14, 2017 and Sep 9, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement1
- Sensing Intermittently1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE SENSOR FAILS RANDOMLY. THE SENSOR, "RANDOMLY STOPS READING; NO ERROR MESSAGES OR ALARMS WERE DISPLAYED ON THE HOST MONITOR". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23012346 ↗MalfunctionNov 14, 2017Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE SENSORS ARE GIVING A CONSTANT 0 READING FOR SPCO. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7028556 ↗
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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