RD SET™ Inf SpO2, PR, PI, PVI® Infant Pulse Oximeter Adhesive Sensor 4002Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10843997009581), received between Jan 13, 2017 and Dec 30, 2021 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE DEVICE WAS MALFUNCTIONING AND GIVING INACCURATE READINGS BASED ON ASSESSMENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122312 ↗
• MalfunctionJun 24, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THE SENSOR IS READING LOW. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063221 ↗
• MalfunctionApr 26, 2019Low Readings; Low Readings

  THE CUSTOMER REPORTED THE SENSOR PROVIDED INACCURATE LOWER READING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8558251 ↗
• MalfunctionDec 27, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED A BATCH OF RD SET INF AND RD SET NEO PROBES REJECTED BECAUSE HAVE SEEN SPECTRAL DEVIATION OF -4% (AT 70% SATURATION) IN SEVERAL PROBES. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148124 ↗
• 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 6823330 ↗
• MalfunctionJun 10, 2017Failure To Adhere Or Bond; Incorrect Measurement; Failure To Adhere Or Bond; Incorrect Measurement

  THE CUSTOMER REPORTED THAT ADHESIVE QUALITY ON RD SENSORS ARE NOT AS RELIABLE AS PREVIOUS VERSIONS, CUSTOMER ALSO REPORTING THAT RD SENSOR IS READING LOW SP02. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6632744 ↗
• MalfunctionMar 30, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED A (B)(6), FEMALE, NON-INVASIVELY VENTILATED PATIENT WHO NORMALLY RUNS 80-85% O2 SATURATIONS WAS DISPLAYING AN O2 SATURATION OF 65% WITH 3-STARS, YET THE PATIENT LOOKED PHYSIOLOGICALLY STABLE. THE PATIENT HAD AN RD SET INF-L SENSOR ON THE (L) GREAT TOE. DEBBIE AND STEPHANIE FOLLOWED TROUBLESHOOTING TIPS, PUT ON A NEW INF-L SENSOR AND REPOSITIONED TO THE (R) GREAT TOE. THE PATIENT STILL HAD AN O2 SATURATION OF 65-69% WITH 3 STARS ON THE GE MONITOR. IT WAS DECIDED BY THE NURSES TO PUT THE PATIENT ON AN LNOP NEO-L SENSOR ON THE (L) GREAT TOE. THERE WAS AN 8% POINT DIFFERENCE ONCE THE LNOP NEO- L SENSOR WAS PLUGGED IN TO THE GE CARESCAPE BX50 MONITOR, WITH THE LNOP SENSOR READING 72%. FURTHER TROUBLESHOOTING WITH THE RD SET INF-L SENSOR IMPROVED SLIGHTLY, BUT STILL AT A 5-6% DIFFERENCE WITH 3-STARS, WITH THE LNOP SENSOR READING HIGHER. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6445805 ↗
• MalfunctionMar 30, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED ROOM 12 IN THE PICU BECAUSE THE SPO2 WAS ¿BOUNCING¿ AROUND. I OBSERVED SPO2 FLUCTUATING FROM 88% TO 93% TO 92% TO 96% ALL WITHIN ABOUT 20 SECONDS. THIS IS A (B)(6) WEIGHING KG. NEO SENSOR WAS ON RIGHT BIG TOE AND DETECTOR ON NAILBED. RN REPOSITIONED SENSOR CORRECTLY ON RIGHT TOE AND NUMBERS STILL FLUCTUATING. AN INFANT SENSOR WAS THEN PLACED ON LEFT BIG TOE, CORRECTLY ALIGNED AND POSITIONED AND SPO2 STILL FLUCTUATING. RN DID NOT BELIEVE IT WAS PHYSIOLOGICAL AND GRABBED AN LNOP SENSOR AND CABLE AND PLACED ON LNOP INFANT SENSOR ON PT.¿S LEFT BIG TOE. THE LNOP SENSOR STILL HAD THE VARIABILITY, BUT DID NOT GO BELOW 90%. THE RN PLACED RD INFANT SENSOR ON PT.S RIGHT BIG TOE AND WE WERE ABLE TO SEE, IN REAL TIME, THAT SPO2 VALUES WITH BOTH SENSORS VARIED, BUT THE RD SENSOR FLUCTUATED DOWN TO 87% -88% WHILE THE LNOP SENSOR DIDN¿T GO BELOW 90%. WE THEN SWITCHED SENSORS TO SEE IF THERE WAS SITE BIAS AND THE RD SENSOR CONTINUED TO READ DOWN TO 87-88% WHILE THE LNOP DID NOT. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6445645 ↗
• MalfunctionMar 24, 2017Device Stops Intermittently; Device Stops Intermittently

  IT WAS REPORTED THAT THE PATIENT WAS DESATURATING TO 86%, HOWEVER THE PATIENT LOOKED CLINICALLY OKAY. THE NURSE DISCONNECTED & RECONNECTED THE RD SET INF-L SENSOR AND THE INF-L SENSOR STARTED WORKING. LATER IN THE DAY WITH THE SAME PROBE, ANOTHER NURSE WAS UNABLE TO GET A 3-STAR READING DESPITE REPOSITIONING. THE PATIENT'S O2 SATURATION WAS 93% AND NOTED THAT THE SENSOR IS LESS THAN 8 HOURS OLD. SHE ENDED UP CHANGING OUT THE PROBES. THIS IS A PROBLEM, BECAUSE THE NURSES/CUSTOMERS EXPECT QUALITY READINGS TO DISPLAYED AS QUALITY 3-STAR READINGS ON THE MONITOR WHEN PERCEIVED CORRECT SENSOR PLACEMENT IS PERFORMED. SENSOR WAS SAVED AND PLACED IN A BAG TO BE SENT IN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6434271 ↗
• MalfunctionMar 24, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED AFTER A LAB DRAW ON THE LEFT ARM, A NICU PATIENT'S MONITOR DISPLAYED AN O2 DESATURATION EVENT THAT WENT AS LOW AS 27% WITH A PULSE RATE OF 66 BPM. HOWEVER, PER THE NURSE, BASED ON PATIENT ASSESSMENT, THE PATIENT LOOKED PINK, WAS IN NO DISTRESS, AND HAD A NORMAL HEART RATE ON EKG OF 153 BPM THAT DID NOT SIGNIFY RESPIRATORY DISTRESS. THE ISSUE WAS NOTED AT 15:53PM ON (B)(6) 2017. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6434104 ↗
• MalfunctionMar 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  CUSTOMER REPORTS THAT SPO2 DROPS OUT AND FLAT LINES WHEN PT. HR DROPS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6415736 ↗
• MalfunctionMar 15, 2017Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PEDIATRIC ICU NURSE INDICATED THAT THE RD INF SENSOR ON A PATIENT'S FOOT OF A 8 MONTHS OLD 6 KG BABY WAS READING SPO2 IN THE LOW 70S. THE CUSTOMER USED TO GET NUMBERS IN THE 80S WITH AN LNOP SENSOR. THE RN WAS ADAMANT THAT THE PATIENT'S NORMAL SPO2 IS AROUND 80-81%. THE RN STATED THAT SHE HAS TAKEN CARE OF THIS PATIENT FOR 8 MONTHS AND SHE KNOWS THE 80% SPO2 RANGES ARE CORRECT.

  Patient problems: Congestive Heart Failure

  MAUDE report 6405862 ↗
• MalfunctionFeb 13, 2017Incorrect Measurement; Device Stops Intermittently; Incorrect Measurement; Device Stops Intermittently

  THE CUSTOMER REPORTED WHEN THE SENSOR IS FIRST CONNECTED EVERYTHING WORKS FINE FOR 30-120 MINUTES; THEN THE READING "GOES AWAY." THE CUSTOMER WOULD DISCONNECT AND RECONNECT THE SENSOR TO GET THE READING BACK, BUT THIS STRATEGY NO LONGER WORKED. IT WAS ALSO INDICATED THAT THE SENSOR READINGS WOULD FLUCTUATE SIGNIFICANTLY LOWER TO HIGHER AND THEN STABILIZE. READINGS WOULD DROP DOWN INTO THE 70'S BEFORE MIGRATING BACK UP AND STABILIZING INTO THE MID 90'S. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6325655 ↗
• MalfunctionFeb 13, 2017Incorrect Measurement; Device Stops Intermittently; Incorrect Measurement; Device Stops Intermittently

  THE CUSTOMER REPORTED WHEN THE SENSOR IS FIRST CONNECTED EVERYTHING WORKS FINE FOR 30-120 MINUTES; THEN THE READING "GOES AWAY." THE CUSTOMER WOULD DISCONNECT AND RECONNECT THE SENSOR TO GET THE READING BACK, BUT THIS STRATEGY NO LONGER WORKED. IT WAS ALSO INDICATED THAT THE SENSOR READINGS WOULD FLUCTUATE SIGNIFICANTLY LOWER TO HIGHER AND THEN STABILIZE. READINGS WOULD DROP DOWN INTO THE 70'S BEFORE MIGRATING BACK UP AND STABILIZING INTO THE MID 90'S. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6325647 ↗
• MalfunctionJan 15, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT WHEN USING A COMPARATOR DEVICE, THE READINGS WERE "OBVIOUSLY NOT THE REAL NUMBER." THE PULSE OX CONTINUED TO SCAN, BUT DOES NOT SUCCESSFULLY READ A VALUE WHEN THE PATIENT CONTINUOUSLY MOVES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6252859 ↗
• MalfunctionJan 15, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED THE DEVICE STOPPED READING. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6252857 ↗
• MalfunctionJan 13, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED THE UNIT STOPPED READING. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6252069 ↗