RD rainbow SET-2 4029Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10843997010938), received between Jun 11, 2019 and Mar 16, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Sensing Intermittently” (5 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2023Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE VALUE WAS MEASURED NORMALLY THEN THE MEASUREMENT IS STOPPED. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554324 ↗
• MalfunctionJan 13, 2023Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED SPO2, SPHB, AND PVI VALUES DISAPPEARED AFTER TRACHEAL INTUBATION. NO CONSEQUENCES OR PATIENT IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162775 ↗
• MalfunctionApr 28, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THERE WAS A GAP BETWEEN THE SENSOR SPHB AND THE LAB HB. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14243842 ↗
• MalfunctionJul 22, 2021Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THAT THE "SPHB VALUE WAS NOT CONSISTENT AND THE FIGURE CONTINUES TO BE DISCONNECTED." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214639 ↗
• MalfunctionJun 15, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THE DEVICE PROVIDED LOW SPHB VALUES WHEN COMPARED TO A LAB VALUE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12003858 ↗
• MalfunctionJan 31, 2020Sensing Intermittently; High Readings; Sensing Intermittently; High Readings

  THE CUSTOMER REPORTED HIGH SPHB VALUES AND THE DEVICE ENTERS SPO2 MODE ONLY AND THE SPHB DROPS OFF. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9653770 ↗
• MalfunctionJul 16, 2019Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED INACCURATE MEASUREMENTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795184 ↗
• MalfunctionJun 11, 2019Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THAT AFTER 10 MINUTES OF MONITORING IT STOPPED MEASURING. AFTER A WHILE IT STARTED MEASURING AGAIN WITH NO PROBLEM FOR MEASUREMENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689811 ↗