RD SET™ MD20-1.5 RD SET Series Patient Cable 4102Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843997010290), received between Mar 4, 2017 and Mar 4, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect Measurement” (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
- Incorrect Measurement1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2017Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT "THE CUSTOMER NOTIFIED MASIMO CS THAT THEY CAN'T SEEM TO GET A GOOD CONFIDENT READING WHILE IN FLIGHT ON THE HELICOPTER. THEY ARE AWARE AND COVERING THE SENSORS SO LIGHT DOES NOT INTERFERE. THE COMPLAINT IS THAT THE MOVEMENT AND MOTION SEEMS TO BE THE PROBLEM WITH THE NEW RD SET SENSORS AND CABLES". NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6378985 ↗
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- 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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