RD SET 4478Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10843997013267), received between Sep 4, 2020 and Apr 6, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Sensing Intermittently” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Failure to Sense

  THE CUSTOMER REPORTED ¿PLUGGED THE NICU OXIMETER PROBE INTO THE CABLE AND IT SAID, "FAULTY PROBE" AND WOULD NOT WORK RIGHT AFTER OPENING". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787390 ↗
• MalfunctionMar 26, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PER MEDWATCH REPORT (B)(4), THE CUSTOMER REPORTED THAT THE SENSOR "WAS READING SENSOR MALFUNCTION OFF AND ON THROUGHOUT THE DAY WITH LARGE VARIATIONS IN OXYGEN SATURATION AT TIMES THAT WOULD QUICKLY RESOLVE". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699128 ↗
• MalfunctionNov 25, 2024Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THAT THE SENSOR "WAS WORKING ON INTERMITTENTLY", WHERE IT "FAILED TO READ. PULSE OXIMETER WAS REPOSITIONED SEVERAL TIMES WITHOUT SUCCESSFUL RETURN TO FUNCTION...UNABLE TO ESTABLISH A CONSISTENT, RELIABLE, AND ACCURATE PULSE OXIMETER READING". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774742 ↗
• MalfunctionOct 3, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  PER MEDWATCH (B)(4) THE CUSTOMER REPORTED THAT THE "PATIENT'S MONITOR SAID THAT THE PULSE OXIMETER WAS OFF PATIENT. THE SENSOR WAS STILL ON THE PATIENT AND EVERYTHING WAS CONNECTED." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363886 ↗
• MalfunctionJul 22, 2024Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER REPORTED "PATIENT WAS HAVING DESATURATIONS THROUGHOUT THE DAY. THE MASIMO PULSE OXIMETER WOULD STOP READING AND I COULD NOT GET AN OXYGEN SATURATION READING FOR MINUTES. PATIENT WAS BLUE AND NEEDED AN INCREASE IN OXYGEN. IT WAS HARD TO TELL HOW MUCH OXYGEN HE WAS NEEDING DUE TO THE PULSE OXIMETER NOT PICKING UP A SATURATION". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19802381 ↗
• MalfunctionMay 1, 2024Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED, PER THE MEDWATCH "WHILE ON TRANSPORT AND WHILE GETTING READY TO INTUBATE PATIENT, OXYGEN SATURATION PROBE WENT FLATLINE AND STOPPED READING. AFTER INTUBATING PATIENT AND GETTING SETTLED, REPLACED OXYGEN SATURATION PROBE WITH A NEW ONE AND STARTED WORKING AGAIN." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226521 ↗
• MalfunctionMay 1, 2024Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED VIA THE MEDWATCH REPORT "O2 SATURATION PROBE STOPPED WORKING. IT WAS UNPLUGGED AND PLUGGED BACK IN AND TRIED ANOTHER LIMB. THE RED LIGHT DID NOT COME ON". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226389 ↗
• MalfunctionMay 1, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED EXPOSED WIRES ON THE CABLE. THERE WAS NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226338 ↗
• MalfunctionMay 1, 2024Incorrect Measurement; Unable to Obtain Readings; Incorrect Measurement; Unable to Obtain Readings

  THE CUSTOMER REPORTED "PULSE OXIMETER FAILURE - WAS READING WELL PRIOR TO INTUBATION, PATIENT LOCKED CHEST DURING INTUBATION MEDICATION. SATURATIONS BEGAN TO DROP, SAW 60, 50S, AND THEN WAS UNREADABLE DURING INTUBATION UNTIL IT FINALLY CAME BACK AFTER PATIENT WAS STABILIZED AND SATURATIONS WERE 80S AGAIN." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226319 ↗
• MalfunctionApr 9, 2024

  MODEL 4478- WHILE ON TRANSPORT AND WHILE GETTING READY TO INTUBATE PATIENT, OXYGEN SATURATION PROBE WENT FLATLINE AND STOPPED READING. AFTER INTUBATING PATIENT AND GETTING SETTLED, REPLACED OXYGEN SATURATION PROBE WITH A NEW ONE AND STARTED WORKING AGAIN. MODEL 2320- PULSE OXIMETER LOW NOISE CABLED SENSOR (LNCS) FOUND TO HAVE EXPOSED WIRES. MODEL 2320- BEDSIDE REGISTERED NURSE (RN) DISCOVERED OXYGEN SATURATION PROBE WAS FRAYED WITH EXPOSED WIRES ON INFANT¿S SKIN. NO HARM TO PATIENT. MODEL 4013- PULSE OXIMETER FLATLINED ON MONITOR. NOTICED ON CENTRAL MONITOR BUT DID NOT ALARM. WENT INTO ROOM AND BABY WAS RESTING COMFORTABLY. SATURATION MONITOR WAS STILL ON FOOT AND PROPERLY POSITIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070607 ↗
• MalfunctionDec 7, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTED " THE NEW MASIMO RD SET O2 PROBES ARE CONSTANTLY HAVING THE PROTECTIVE COVERING TO THE WIRE COME UNDONE AND EXPOSE THE WIRES REQUIRING MORE FREQUENT CHANGES OF THE WHOLE O2 SATURATION PROBE RATHER THAN JUST THE STICKER. SINCE THE CHANGE, REGISTERED NURSES (RNS) ARE NOTICING MORE OF AN ISSUE WITH WIRE EXPOSURE AND INTEGRITY, MORE FREQUENT CHANGING OF THE ENTIRE CORD DUE TO THIS AND ISSUES WITH THE O2 SAT PROBES NOT PICKING UP AT TIMES COMPARED TO THE PREVIOUS BRAND WE USED AND REQUIRING A CHANGE EVEN IF THE CORD IS INTACT." THERE WERE NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18285893 ↗
• MalfunctionSep 20, 2023Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED "PULSE OX WAS NOT READING APPROPRIATELY. WHEN ON PATIENT'S FOOT, IT WOULD FAIL TO PICK-UP ANY READINGS. WHEN DISCONNECTED AND RECONNECTED, IT PICKED UP BRIEFLY, BUT DID NOT GIVE AN ACCURATE READING (POOR PHOTOPLETHYSMOGRAPH AND PULSE READING ON PULSE OXIMETER DID NOT CORRELATE WITH ELECTROCARDIOGRAM(ECG) HEART RATE)." THERE WAS NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786441 ↗
• MalfunctionSep 4, 2020Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE SPO2 CURVE OR VALUE DISAPPEARED FROM THE MONITORING DISPLAY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10495969 ↗