AIRFIT F30I 63370Recalls & reported problems
Resmed Pty Ltd · AIRFIT F30I CONDUIT LGE · 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 00619498633708), received between May 3, 2024 and May 3, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2024Break; Break
IT WAS REPORTED TO RESMED THAT A PIECE OF AN AIRFIT F30I MASK BROKE OFF WHILE IN USE ON A PATIENT. IT WAS REPORTED THAT THE PATIENT MAY HAVE SWALLOWED THE BROKEN PIECE DURING THE NIGHT WHILE ASLEEP. THERE WAS NO REPORT OF THE PATIENT SEEKING MEDICAL ATTENTION OR TREATMENT DUE TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19243327 ↗MalfunctionMay 3, 2024Break; Break
IT WAS REPORTED TO RESMED THAT A PIECE OF AN AIRFIT F30I MASK BROKE OFF WHILE IN USE ON A PATIENT. IT WAS REPORTED THAT THE PATIENT MAY HAVE SWALLOWED THE BROKEN PIECE DURING THE NIGHT WHILE ASLEEP. THERE WAS NO REPORT OF THE PATIENT SEEKING MEDICAL ATTENTION OR TREATMENT DUE TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19243325 ↗
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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 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.
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