NewLife Intensity 10 AS099-101Recalls & reported problems
Caire Inc. · NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, 02 MONITOR · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M766AS0991010), received between Aug 12, 2024 and Aug 12, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2024Use of Device Problem; Use of Device Problem
AS REPORTED: PATIENT ATTEMPTED TO SMOKE WHILE WEARING HIS OXYGEN AND SUSTAINED SECOND DEGREE BURNS TO BILATERAL NARES. HE WENT TO BED AND WOKE UP AT 4AM HAVING DIFFICULTY BREATHING AND CALLED 911 TO TAKE HIM TO THE HOSPITAL FOR TREATMENT. PATIENT IS A KNOWN SMOKER.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 19968073 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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