SpO2 Sensor M1193A Reus Neo H-F SpO2 Sensor (1.5m)Recalls & reported problems
Philips Medizin Systeme Böblingen GmbH · M1193A Reusable Neonatal Hand/Foot SpO2 Sensor (1.5m) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838102705), received between Aug 30, 2024 and Apr 21, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Incorrect Measurement” (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.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement1
- Temperature Problem1
Patient problems
- Burn(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Incorrect Measurement
IT WAS REPORTED THAT EQUIPMENT IS PROVIDING INTERMITTENT READINGS FOR OXYGEN SATURATION. IT WAS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940721 ↗InjuryAug 30, 2024Temperature Problem; Temperature Problem
IT WAS REPORTED A BURN DEVELOPED ON THE INFANT'S ARM WHERE THE SPO2 SENSOR WAS APPLIED. IT WAS INDICATED MEDICAL ATTENTION WAS SOUGHT. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. AN ADVERSE EVENT INVOLVING A PATIENT WAS REPORTED.
Patient problems: Burn(s)
MAUDE report 20109207 ↗
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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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