RD SET™ DCI SpO2 Adult Reusable Finger Clip Sensor 4050Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00843997009843), received between Mar 11, 2017 and Sep 25, 2026 — classified as 1 injury, 40 malfunctions.

The most frequently reported specific device problem is “Device Stops Intermittently” (8 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. 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Incorrect Measurement

  The customer reported "inconstant readings." There was no patient impact or consequence reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894860 ↗
• MalfunctionApr 21, 2026High Readings

  THE CUSTOMER REPORTED THAT THE MASIMO SENSOR AND CABLE PROVIDED AN SPO2 OF 100% WHILE BLOOD GAS ANALYSIS SHOWED 85% AND A 3RD PARTY MONITOR SHOWED 87%. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24934247 ↗
• MalfunctionApr 21, 2026High Readings

  THE CUSTOMER REPORTED "SPO2 99 PERFUSION INDEX 2.28 GOOD QUALITY PLETHYSMOGRAPHIC WAVEFORM MEASUREMENT REMAINED UNCHANGED EVEN WITH THE HAND COVERED. ARTERIAL BLOOD GAS ANALYSIS SAO2 88.8". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24934143 ↗
• MalfunctionMar 14, 2026High Readings

  THE CUSTOMER REPORTED THE SENSOR "SPO2 MEASUREMENT STABLE AT 93% IN COPD PATIENT, AND CONCOMITANT MEASUREMENT SAO2 AT 84.4% (DIFFERENTIAL >8%)." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601474 ↗
• MalfunctionFeb 5, 2026Incorrect Measurement

  THE CUSTOMER REPORTED, "UNDER LOW-LIGHT CONDITIONS (BED HEADBOARD LAMP), AT APPROXIMATELY 5:00 PM, THE PULSE OXIMETER SHOWING A GOOD PLETHYSMOGRAPHIC WAVEFORM AND AN ADEQUATE PERFUSION INDEX INDICATED AN SPO2 OF 99%. THE PATIENT HAD WARM SKIN. THE SENSOR WAS TESTED ON SEVERAL FINGERS OF AN UNSPECIFIED HAND. AT THE TIME OF ARTERIAL BLOOD GAS ANALYSIS, THE MEASURED OXYGEN SATURATION WAS 78%. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274989 ↗
• MalfunctionJan 21, 2026Loose or Intermittent Connection; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE "SATURATION OF PERIPHERAL OXYGEN (SPO2) PROBES ARE ON CARDIAC MONITORING DEFIBRILLATORS AND HAVE BEEN EXHIBITING INTERMITTENT FAULTS LEADING TO NO OR FALSE AND INACCURATE READINGS WITH HIGH HEART RATE;" "INTERMITTENT PULSE OXIMETER PHOTOPLETHYSMOGRAPH, AND SPO2 READINGS ON THE CARDIAC MONITORING DEFIBRILLATOR". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: Anxiety

  MAUDE report 24127703 ↗
• MalfunctionJan 21, 2026Loose or Intermittent Connection; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE "SATURATION OF PERIPHERAL OXYGEN (SPO2) PROBES ARE ON CARDIAC MONITORING DEFIBRILLATORS AND HAVE BEEN EXHIBITING INTERMITTENT FAULTS LEADING TO NO OR FALSE AND INACCURATE READINGS WITH HIGH HEART RATE"; "INTERMITTENT PULSE OXIMETER PHOTOPLETHYSMOGRAPH, AND SPO2 READINGS ON THE CARDIAC MONITORING DEFIBRILLATOR". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: Anxiety

  MAUDE report 24127421 ↗
• MalfunctionJan 21, 2026Loose or Intermittent Connection; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE "SATURATION OF PERIPHERAL OXYGEN (SPO2) PROBES ARE ON CARDIAC MONITORING DEFIBRILLATORS AND HAVE BEEN EXHIBITING INTERMITTENT FAULTS LEADING TO NO OR FALSE AND INACCURATE READINGS WITH HIGH HEART RATE"; "INTERMITTENT PULSE OXIMETER PHOTOPLETHYSMOGRAPH, AND SPO2 READINGS ON THE CARDIAC MONITORING DEFIBRILLATOR". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: Anxiety

  MAUDE report 24127389 ↗
• MalfunctionJan 21, 2026Loose or Intermittent Connection; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE "SATURATION OF PERIPHERAL OXYGEN (SPO2) PROBES ARE ON CARDIAC MONITORING DEFIBRILLATORS AND HAVE BEEN EXHIBITING INTERMITTENT FAULTS LEADING TO NO OR FALSE AND INACCURATE READINGS WITH HIGH HEART RATE;" "INTERMITTENT PULSE OXIMETER PHOTOPLETHYSMOGRAPH, AND SPO2 READINGS ON THE CARDIAC MONITORING DEFIBRILLATOR". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: Anxiety

  MAUDE report 24127374 ↗
• MalfunctionJan 21, 2026Loose or Intermittent Connection; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE "SATURATION OF PERIPHERAL OXYGEN (SPO2) PROBES ARE ON CARDIAC MONITORING DEFIBRILLATORS AND HAVE BEEN EXHIBITING INTERMITTENT FAULTS LEADING TO NO OR FALSE AND INACCURATE READINGS WITH HIGH HEART RATE;" "INTERMITTENT PULSE OXIMETER PHOTOPLETHYSMOGRAPH, AND SPO2 READINGS ON THE CARDIAC MONITORING DEFIBRILLATOR". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: Anxiety

  MAUDE report 24127369 ↗
• MalfunctionJun 10, 2025Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED EXPERIENCING "DROPOUTS AND READINGS COMING IN AND OUT" WITH THE CABLES AND SENSOR.. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177514 ↗
• MalfunctionJun 9, 2025Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE CABLES AND SENSORS "DROPPED OUT." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172532 ↗
• MalfunctionOct 29, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PER MEDWATCH #MW5159272, THE CUSTOMER REPORTED "ON SKIN CHECK, NOTED A DISCOLORED AREA UNDER THE NAIL JUST BELOW WHERE THE PROBE WAS SITTING ON THE NAIL". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: Bruise/Contusion; Skin Discoloration

  MAUDE report 20557699 ↗
• MalfunctionMay 10, 2024Unintended Electrical Shock; Unintended Electrical Shock

  THE CUSTOMER REPORTED "PATIENT REPORTED SHE FELT SHOCK SENSATION THROUGH HER RIGHT HEEL UP INTO HER LEG. HUSBAND REMOVED SENSOR PROBE FROM HER RIGHT TOE AND CALLED FOR RN. PT DENIES ANY FURTHER PAIN OR DISCOMFORT. PER RN NO VISUAL SIGNS OF INJURY TO PATIENT." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293840 ↗
• MalfunctionJul 11, 2023High Readings; High Readings

  THE CUSTOMER REPORTED A MEASURED SPO2 VALUE OF 98% COMPARED TO 82.5% WITH THE BLOOD GAS ANALYZER. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302920 ↗
• MalfunctionJul 11, 2023High Readings; High Readings

  THE CUSTOMER REPORTED A MEASURED SPO2 VALUE OF 98% COMPARED TO 88% WITH THE BLOOD GAS ANALYZER. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302915 ↗
• MalfunctionApr 8, 2022Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THAT THE SENSOR CUT OUT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14059849 ↗
• MalfunctionMar 26, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE SENSOR IS NOT DISPLAYING ACCURATELY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13922455 ↗
• MalfunctionMay 6, 2021Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED INTERMITTENT SPO2 DROPOUTS AND READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787164 ↗
• MalfunctionApr 6, 2021Incorrect Measurement; Sensing Intermittently; Incorrect Measurement; Sensing Intermittently

  THE CUSTOMER REPORTED THE SENSOR IS INTERMITTENTLY SEEING BASELINE WANDER AND INTERMITTENTLY WORKING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625004 ↗
• MalfunctionDec 5, 2020Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE SENSOR PROVIDED DESATURATIONS AND FALSE VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10950394 ↗
• MalfunctionJan 31, 2019Break; Break

  THE CUSTOMER REPORTED SENSOR HAS A BROKEN TAB AT THE CONNECTOR END, CAUSING AN INTERMITTENT SPO2 READING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8293917 ↗
• MalfunctionOct 22, 2018Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE SENSOR HAS AN INTERMITTENT CONNECTION WHEN BENDING THE IN-LINE CONNECTOR. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7993078 ↗
• MalfunctionApr 1, 2018Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED SENSORS "JUST STOPPED WORKING" NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7387855 ↗
• MalfunctionFeb 16, 2018Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED: "RD REUSABLE FINGER PROBE, PART NUMBER 4050, SPLITTING AT CASING OF SENSOR CONNECTION END; THEREFORE CAUSING INTERMITTENT READINGS, DROPPING OUT SIGNALS, AND CAUSING ISSUES OVERALL WITH MONITORING EFFECTIVELY AND ACCURATELY." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7279221 ↗