RD rainbow SET™ MD20-12 RD rainbow SET Series Patient Cable 4073Recalls & reported problems
Masimo Corporation · 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 00843997009744), received between Feb 19, 2018 and Jul 29, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Device Stops Intermittently2
- Incorrect Measurement2
- Low Readings1
- Sensing Intermittently1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2022Low Readings; Low Readings
THE CUSTOMER REPORTED SPO2 VARIANCE FOUND DURING TESTING ON A PRETERM INFANT PATIENT AND REPORTED THE SPO2 READINGS WERE FLUCTUATING BELOW THE EXPECTED SPO2 READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15136142 ↗MalfunctionDec 30, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE INTERMITTENTLY CUTS OUT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11099190 ↗MalfunctionFeb 19, 2018Break; Incorrect Measurement; Device Stops Intermittently; Break; Incorrect Measurement; Device Stops Intermittently
THE CUSTOMER REPORTED THE CABLE IS SPLITTING AT THE SENSOR CONNECTION END, CAUSING INTERMITTENT READINGS, DROPPING OUT SIGNALS, AND OVER ISSUES WITH EFFECTIVE AND ACCURATE MONITORING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7281004 ↗MalfunctionFeb 19, 2018Break; Incorrect Measurement; Device Stops Intermittently; Break; Incorrect Measurement; Device Stops Intermittently
THE CUSTOMER REPORTED THE CABLE IS SPLITTING AT THE SENSOR CONNECTION END, CAUSING INTERMITTENT READINGS, DROPPING OUT SIGNALS, AND OVER ISSUES WITH EFFECTIVE AND ACCURATE MONITORING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7281003 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page