rainbow® DCI® SC 200 SpHb® SpO2 SpMet® 200 spot checks Adult Reusable Sensor 3418Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843997007269), received between Jan 28, 2018 and Feb 26, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (1 report).

1 other recall cover devices cleared under the same FDA submission (K080238); they may or may not involve this specific model.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THEY ARE SEEING A THREE POINT DIFFERENCE IN THE SPHB READING FROM THE PRONTO AND A BLOOD DRAW. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7298458 ↗
• MalfunctionJan 28, 2018Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED: "INTERMITTENTLY LOSING SIGNAL." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7224039 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080238. One submission often covers many models, so check the product and lot details in each record.

• Z-0338-2016 · Oct 28, 2015 · Terminated
  rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW