rainbow 3797Recalls & reported problems
Masimo Corporation · rainbow DCI - mini SC 200 reusable sensor · 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 00843997008976), received between Jan 4, 2019 and Mar 14, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “High Readings” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- High Readings2
- Incorrect Measurement1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE SPHB MEASUREMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8422968 ↗MalfunctionMar 14, 2019High Readings; High Readings
THE CUSTOMER REPORTED INACCURATELY HIGH SPHB MEASUREMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8422967 ↗MalfunctionJan 4, 2019High Readings; High Readings
THE CUSTOMER REPORTED THE DEVICE PROVIDED HIGHER THAN EXPECTED READINGS. THEY HAD TO CONTACT DONOR TO ADMINISTRATE FE AND SPECIAL FOOD TO COMPENSATE THE INJURY (BLOOD EXTRACTION). NO SERIOUS PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8220295 ↗
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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.