RD SET™ Adt SpO2, PR, PI, PVI® Adult Pulse Oximeter Adhesive Sensor 4000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10843997009567), received between Jan 5, 2017 and Jan 6, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Stops Intermittently” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2023Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT THE ROOT SHOWED SATURATION AT 87%, THE SENSOR WAS CHANGED TO AN EAR PROBE AND IT MEASURED AT 100%. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118420 ↗
• MalfunctionDec 16, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED A DIFFERENCE OF SPO2 READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000271 ↗
• MalfunctionAug 27, 2021Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE DEVICE BECAME DISCONNECTED. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378486 ↗
• MalfunctionAug 25, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE SENSOR READING PROVIDED A LOWER READING THAN ANOTHER SENSOR. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368172 ↗
• MalfunctionOct 4, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE SENSOR PROVIDED INCORRECT READINGS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7932929 ↗
• MalfunctionFeb 3, 2018Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED AT 0940 ON (B)(6) 2018 RN CALLED MASIMO CS ON SITE TO ROOM 10F BED 12 AS POX WAS NOT PICKING UP. RD ADT ON L MIDDLE FINGER WITH TOP ADHESIVE FLAPS WRAPPED AROUND THE FINGER FIRST AND THEN THE BOTTOM ADHESIVE FLAPS OVER THE TOP. ATTEMPTED NEW ADT ON R RING FINGER AND WOULD PICK UP INTERMITTENTLY AND THEN DROP OUT WITH FLAT LINE. CHANGED CABLE AND ATTACHED TO NEW SENSOR AND OBTAINED SIGNAL. PULLED OLD CABLE AND SENSOR. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7239762 ↗
• MalfunctionDec 21, 2017Device Stops Intermittently; Device Stops Intermittently

  IT WAS REPORTED: "SPO2 DROPOUTS AFTER ALL PARAMETERS DROPPED OUT." NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7140784 ↗
• MalfunctionAug 28, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED DURING OR INDUCTION SPO2 SIGNAL DROPPED FOR 15-20 SECONDS FOR NO APPARENT REASON. PATIENT STILL/SEDATED NO MOVEMENT. SIGNAL RE-ACQUIRED WITHOUT INTERVENTION. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6823329 ↗
• MalfunctionAug 23, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED THE NEW SENSORS HAS A HIGH FAILURE RATE OUT OF THE BOX AND INTERMITTENT FAILURE AFTERWARDS, THE RED LIGHT WOULD NOT LIGHT UP OR WOULD NOT STAY ON. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6812635 ↗
• MalfunctionJan 9, 2017Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE RD ADTX WAS PLACED ON THE PATIENT AND WORKING FINE, THEN THERE WAS NO PLETH WAVEFORM OR SPO2 VALUE. THE SENSOR WAS CHECKED BY THE MD AND NO LIGHT WAS OBSERVED FROM THE EMITTER. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6235727 ↗
• MalfunctionJan 8, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED EMITTER INTERMITTENT FAILURE AFTER SEVERAL MINUTES OF USE. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6231972 ↗
• MalfunctionJan 8, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED EMITTER INTERMITTENT SIGNAL LOSS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6231968 ↗
• MalfunctionJan 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT "ANESTHESIOLOGIST REPORTED ONLY A ¿NORMAL" INITIAL READING OF SPO2 AND THEN FLAT LINE OF SIGNAL, THEN OBSERVED ¿LIGHT WENT OUT" ¿ REPLACED SENSOR, AND IT WAS ¿PICKING UP FINE". NO ERROR CODE REPORTED, EMITTER FAILED DIRECTLY AFTER WORKING INITIALLY." NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6226242 ↗