rainbow 4485Recalls & reported problems
Masimo Corporation · RC25-4RA EMS rainbow Patient Cable 4ft./1.2m. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843997013420), received between Jul 1, 2021 and Jun 24, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Incorrect Measurement3
- Device Displays Incorrect Message1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE CABLE WAS INACCURATE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14801625 ↗MalfunctionJun 24, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE CABLE WAS INACCURATE WHEN IT IS MOVED. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14801491 ↗MalfunctionJul 1, 2021Incorrect Measurement; Device Displays Incorrect Message; Incorrect Measurement; Device Displays Incorrect Message
THE CUSTOMER REPORTED THAT THE CABLE PROVIDED "CONFUSED VALUES" OR AN ERROR MESSAGE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12100781 ↗
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- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
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- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.