RD SET 4052Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843997014298), received between Feb 21, 2020 and Dec 31, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED "THE SENSOR STOPPED WORKING WHEN THE PATIENT WAS CONNECTED, BUT THERE WAS NO BREAKAGE ON THE DEVICE. THIS TYPE OF SENSOR HAS A HIGHER IMPEDANCE, RESULTING IN A SATURATION READING APPROXIMATELY 8-10 POINTS LOWER THAN ARTERIAL BLOOD GAS ANALYSIS. THIS HAS BEEN REPORTED SEVERAL TIMES BY MY TEAM. THE PERFUSION SIGNAL IS ABOVE 1, INDICATING A GOOD SIGNAL AND WAVEFORM." "THE CLINICIANS OBSERVED A SIGNIFICANT DISCREPANCY BETWEEN THE BLOOD GAS MEASUREMENT AND THE SPO2 MEASUREMENT." THE SPO2 MEASUREMENT FROM THE SENSOR WAS 99% AND THE ABG SO2 MEASUREMENT WAS 83.7%. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936830 ↗
• MalfunctionDec 31, 2025Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED "THE SENSOR STOPPED WORKING WHEN THE PATIENT WAS CONNECTED, BUT THERE WAS NO BREAKAGE ON THE DEVICE. THIS TYPE OF SENSOR HAS A HIGHER IMPEDANCE, RESULTING IN A SATURATION READING APPROXIMATELY 8-10 POINTS LOWER THAN ARTERIAL BLOOD GAS ANALYSIS. THIS HAS BEEN REPORTED SEVERAL TIMES BY MY TEAM. THE PERFUSION SIGNAL IS ABOVE 1, INDICATING A GOOD SIGNAL AND WAVEFORM." "THE CLINICIANS OBSERVED A SIGNIFICANT DISCREPANCY BETWEEN THE BLOOD GAS MEASUREMENT AND THE SPO2 MEASUREMENT." THE SPO2 MEASUREMENT FROM THE SENSOR WAS 99% AND THE ABG SO2 MEASUREMENT WAS 83.7%. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936813 ↗
• MalfunctionFeb 21, 2020Low Readings; Low Readings

  THE CUSTOMER REPORTED THE DEVICE PROVIDED LOW/INCONSISTENT READINGS. THE READING WAS ALSO FLUCTUATING, NOT A STABLE READING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9742302 ↗