AIRFIT F30I 63332Recalls & reported problems

Resmed Pty Ltd · AIRFIT F30I SYS - M/STD - AMER · Class 2

All models of AIRFIT F30I (10)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00619498633326), received between Nov 8, 2024 and Nov 8, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Electromagnetic Interference” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Nov 20, 2023Class IOpen, Classified
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
Z-0542-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

Electromagnetic Interference2

Patient problems

Confusion/ Disorientation2
Dizziness2
Fall2
Irritability2
Loss of consciousness2
Memory Loss/Impairment2
Psychosis2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryNov 8, 2024Electromagnetic Interference; Electromagnetic Interference
IT WAS REPORTED TO RESMED THAT THE MAGNETS OF AN AIRFIT F30I MASK ALLEGEDLY CAUSED THE SETTINGS OF A PATIENT'S ADJUSTABLE MAGNETIC VENTRICULOPERITONEAL SHUNT TO SHIFT RESULTING IN TOO MUCH FLOW OF CEREBROSPINAL FLUID. PATIENT REQUIRED TRANSPORT TO THE HOSPITAL. PATIENT HAS SWITCHED TO A NON-MAGNETIC MASK. PATIENT DID NOT HAVE SYMPTOMS PRIOR TO USE OF THE MASK.
Patient problems: Confusion/ Disorientation; Dizziness; Fall; Irritability; Loss of consciousness; Memory Loss/Impairment; Psychosis
MAUDE report 20645928 ↗
InjuryNov 8, 2024Electromagnetic Interference; Electromagnetic Interference
IT WAS REPORTED TO RESMED THAT THE MAGNETS OF AN AIRFIT F30I MASK ALLEGEDLY CAUSED THE SETTINGS OF A PATIENT'S ADJUSTABLE MAGNETIC VENTRICULOPERITONEAL SHUNT TO SHIFT RESULTING IN TOO MUCH FLOW OF CEREBROSPINAL FLUID. PATIENT REQUIRED TRANSPORT TO THE HOSPITAL. PATIENT HAS SWITCHED TO A NON-MAGNETIC MASK. PATIENT DID NOT HAVE SYMPTOMS PRIOR TO USE OF THE MASK.
Patient problems: Confusion/ Disorientation; Dizziness; Fall; Irritability; Loss of consciousness; Memory Loss/Impairment; Psychosis
MAUDE report 20644726 ↗

Device details

UDI-DI	`00619498633326`
Brand	AIRFIT F30I
Model	63332
Company	Resmed Pty Ltd
Product code	BZD · Ventilator, Non-Continuous (Respirator)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 28, 2023

Device type (GMDN): CPAP/BPAP face mask, reusable

A flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

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All Ventilator, Non-Continuous (Respirator) devices →

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 · each recall links to the FDA recall notice
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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