RD SET NeoPt-500 SpO2, PR, PI, PVI Neonatal Pulse Oximeter Non-Adhesive Sensor 4005Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10843997009895), received between May 3, 2019 and Jul 22, 2024 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (3 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.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement3
- Low Readings2
- Device Sensing Problem1
- Loss of or Failure to Bond1
- Unable to Obtain Readings1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions3
- Low Oxygen Saturation1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2024Device Sensing Problem; Device Sensing Problem
THE CUSTOMER REPORTED "PATIENT'S MONITOR CAME HAD A WARNING THAT SAID "SPO2 REPLACE SENSR". SENSOR WAS REPLACED AND THE WARNING WENT AWAY." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19801273 ↗MalfunctionMay 1, 2024Loss of or Failure to Bond; Unable to Obtain Readings; Loss of or Failure to Bond; Unable to Obtain Readings
THE CUSTOMER REPORTED PER THE MEDWATCH NOTIFICATION "MONITOR READ EQUIPMENT MALFUNCTION AND THE PATIENT'S OXYGEN SATURATION STOPPED READING. UPON INSPECTING FAULTY PULSE OXIMETER, REGISTERED NURSE (RN) NOTICED THE BLACK AND GOLD AREA, THE END THAT CONNECTS INTO THE MONITOR END, HAD PEELED UP AND WAS BENT." THERE WAS NO PATIENT IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19226480 ↗MalfunctionApr 9, 2024
4005- MONITOR READ EQUIPMENT MALFUNCTION AND THE PATIENT'S OXYGEN SATURATION STOPPED READING. UPON INSPECTING FAULTY PULSE OXIMETER, REGISTERED NURSE (RN) NOTICED THE BLACK AND GOLD AREA, THE END THAT CONNECTS INTO THE MONITOR END, HAD PEELED UP AND WAS BENT. 4478- EXPOSED WIRES. 4478- EXPOSED WIRES. 4478- 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. 4478- O2 SATURATION PROBE STOPPED WORKING. IT WAS UNPLUGGED AND PLUGGED BACK IN AND TRIED ANOTHER LIMB. THE RED LIGHT DID NOT COME ON.
Patient problems: Low Oxygen Saturation
MAUDE report 19069791 ↗MalfunctionApr 3, 2023Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16667757 ↗MalfunctionOct 31, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE SPO2 READING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9263277 ↗MalfunctionOct 18, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE PROVIDED LOW SPO2 READINGS IN THE NICU. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9209729 ↗MalfunctionMay 3, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED INACCURATE LOW SPO2 READING THAT DOES NOT MATCH BLOOD GAS READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8580213 ↗MalfunctionMay 3, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED INACCURATE LOW SPO2 READING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8580168 ↗
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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