O3 4235Recalls & reported problems
Masimo Corporation · O3 Sensor Pediatric Adhesive Sensor · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10843997010808), received between Aug 12, 2022 and Aug 12, 2022 — classified as 2 malfunctions.
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
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Pressure Sore/Ulcer2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2022Adverse Event Without Identified Device or Use Problem
A PATIENT HAD PLACEMENT OF NIRS (NEAR-INFRARED SPECTROSCOPY) MONITORS ON THE LOWER LEFT FLANK. THE PATIENT DEVELOPED AN UNSTAGEABLE PRESSURE INJURY AT THE LOCATION OF THE PROBE.
Patient problems: Pressure Sore/Ulcer
MAUDE report 15216530 ↗MalfunctionAug 12, 2022Adverse Event Without Identified Device or Use Problem
PATIENT HAD PLACEMENT OF NIRS (NEAR-INFRARED SPECTROSCOPY) MONITORS ON RIGHT AND LEFT FLANKS AND DEVELOPED PRESSURE INJURIES AT BOTH SITES.
Patient problems: Pressure Sore/Ulcer
MAUDE report 15216491 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page