NA Neo/Infant/Adult Disposable Sp02 SensorRecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Neo/Infant/Adult Disposable Sp02 Sensor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30884838010209), received between Aug 2, 2022 and Aug 2, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Alarm System” (1 report).
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
Device problems
- Device Alarm System1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 2, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED TO PHILIPS THAT THE PHILIPS OXIMETRY PROBE DID NOT ALARM AND HAD A NORMAL VALUE RANGE WHILE THE PATIENT WAS HAVING A "CRISIS OF LIFE". THE PATIENT WAS BEING MONITORED BY ANOTHER DEVICE THAT CORRECTLY ALARMED. THERE WAS PATIENT INVOLVEMENT WAS REPORTED, BUT THERE WAS NO HARM OR AN ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15148012 ↗
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- 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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