RD SET™ DCI-P SpO2 Pediatric/Slender digit Reusable Finger Clip Sensor 4051Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843997009850), received between Apr 7, 2017 and May 11, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K051212); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2020Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE RD SENSOR IS HAVING INTERMITTENT DROPOUT/LOSS OF SIGNAL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10043647 ↗
• MalfunctionJun 8, 2017Break; Device Stops Intermittently; Break; Device Stops Intermittently

  THE CUSTOMER REPORTED SENSORS AND CABLES NOT WORKING DESPITE CLINICAL TROUBLESHOOTING. THE CUSTOMER DOES NOT SEE ANY PHYSICAL DAMAGE TO THE CABLE OR SENSORS IN MOST CASES; HOWEVER, THEY HAVE INDICATED THAT THE RD TAB WILL BREAK EASILY WHEN TRYING TO REMOVE THE CLASP. THESE SENSORS AND CABLES ARE NOT PROVIDING A SPO2 VALUES OR WAVEFORMS, OR ARE VERY INTERMITTENT AND POSITIONAL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6628947 ↗
• MalfunctionJun 8, 2017Break; Device Stops Intermittently; Break; Device Stops Intermittently

  THE CUSTOMER REPORTED SENSORS AND CABLES NOT WORKING DESPITE CLINICAL TROUBLESHOOTING. THE CUSTOMER DOES NOT SEE ANY PHYSICAL DAMAGE TO THE CABLE OR SENSORS IN MOST CASES; HOWEVER, THEY HAVE INDICATED THAT THE RD TAB WILL BREAK EASILY WHEN TRYING TO REMOVE THE CLASP. THESE SENSORS AND CABLES ARE NOT PROVIDING A SPO2 VALUES OR WAVEFORMS, OR ARE VERY INTERMITTENT AND POSITIONAL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6628946 ↗
• MalfunctionMay 19, 2017Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER REPORTED THAT 6 ADDITIONAL RD DCIS WERE NOT WORKING. THIS CUSTOMER HAS HAD PREVIOUS COMPLAINTS ABOUT RD DCIS BREAKING DOWN MUCH MORE QUICKLY THAN THE LNCS EQUIVALENT. PER THE CUSTOMER: "IRONICALLY, WE FOUND OUT THAT 2 MORE NON-DISPOSABLE PROBES WERE NOT WORKING YESTERDAY AFTER A MEDICAL EMERGENCY OF A PATIENT SEIZURING IN OUR ADJACENT XRAY DEPARTMENT. STAFF WERE GETTING FRUSTRATED AS THEY HAD 3 MONITORS AND 3 DIFFERENT SAT PROBES THAT THERE WERE TRYING TO USE TO GET AN OXIMETRY READING. AFTER MUCH TIME AND DELAY, IT WAS DETERMINED THAT 2 OF THE 3 PROBES WERE NOT WORKING. THEY LIT UP BUT DID NOT REGISTER A READING. I THINK I HAVE 6 HERE IN MY OFFICE THAT HAVE NOT HAD LONGEVITY WITH US. THIS CLINICAL SITUATION SURE HIGHLIGHTED OUR CHALLENGES WITH THESE PROBES."

  Patient problems: Seizures

  MAUDE report 6580005 ↗
• MalfunctionApr 7, 2017Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THERE WERE LOW SPO2 READINGS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6473844 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051212. One submission often covers many models, so check the product and lot details in each record.

• Z-1985-2023 · Apr 21, 2023 · Open, Classified
  Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
• Z-1986-2023 · Apr 21, 2023 · Open, Classified
  Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
• Z-2642-2017 · Apr 4, 2016 · Terminated
  MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures,
• Z-2641-2017 · Apr 4, 2016 · Terminated
  Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient und
• Z-2640-2017 · Apr 4, 2016 · Terminated
  SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human pa