RD SET™ MD20-12 RD SET Series Patient Cable 4104Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843997010313), received between Dec 9, 2016 and Feb 17, 2017 — classified as 1 death, 2 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).
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
- Device Displays Incorrect Message1
- Inappropriate or Unexpected Reset1
- Overheating of Device1
- Sensing Intermittently1
Patient problems
- Death1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2017Overheating of Device; Overheating of Device
IT WAS REPORTED THAT " STAFF ARE PULLING OFF CABLE WITHOUT HOLDING THE ACTUAL CONNECTION PIECE ON BOTH THE SENSOR AND CABLE. THE TENSION ON THE CABLE IS CAUSING BREAKDOWN ON THE CABLE". THE PRODUCT WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES. NO ERROR MESSAGE OR AUDIBLE ALARM WAS OBSERVED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6339987 ↗MalfunctionFeb 10, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THAT THE DEVICE TURNS ON AND OFF. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6324472 ↗DeathDec 9, 2016Sensing Intermittently; Device Displays Incorrect Message; Sensing Intermittently; Device Displays Incorrect Message
IT WAS REPORTED THAT THE CABLE SOMETIMES DOESN'T WORK AND THE MEASURING DEVICE (RAD-8) SHOWS THE ERROR MESSAGE "SEN OFF". THE PATIENT WAS BEING MONITORED AT HOME WITH THE CABLE HAS EXPIRED ON (B)(6) 2016.
Patient problems: Death
MAUDE report 6158917 ↗
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