AirLife M1004132Recalls & reported problems
Carefusion Finland 320 Oy · HMEF 750/S, Disposable · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403284151), received between Oct 30, 2020 and Oct 30, 2020 — classified as 1 death.
The most frequently reported specific device problem is “Filtration 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.
Most reported problems
Device problems
- Filtration Problem1
Patient problems
- Respiratory Failure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathOct 30, 2020Filtration Problem; Filtration Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR ALARMS ON HIGH PRESSURE, LOW MINUTE VENTILATION, SET-ALARM-UNDERSHOOT WERE GENERATED. THE DOCTOR DISCHARGED THE PATIENT FROM THE VENTILATOR AND SWITCHED TO AN AMBU BAG, BUT THE PATIENT PASSED AWAY 20 MINUTES LATER. THE CUSTOMER CONFIRMED THAT DUE TO THE PATIENT'S PRE-EXISTING HEALTH CONDITION, ACUTE EXACERBATION OF PNEUMOCONIOSIS, HE WAS UNABLE TO SURVIVE. BUT THE PHYSICIAN BELIEVES THAT THE OCCLUSION OF HMEF PLAYED A ROLE IN THE PATIENT'S DEATH.
Patient problems: Respiratory Failure
MAUDE report 10766884 ↗
Other Filter, bacterial, breathing-circuit devices
- VOCSN V+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 recall570 reports
- VOCSN V+Pro Emergency, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit558 reports
- VOCSN V+O+C+S+N+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit3 recalls366 reports
- VOCSN V+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit2 recalls2 deaths325 reports
- VOCSN V+C+S+N+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit185 reports
- GIBECK IPN043751Teleflex Incorporated · Filter, bacterial, breathing-circuit2 recalls7 reports
- VOCSN VOCSN, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 death96 reports
- VOCSN V+C+Pro, JapaneseVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 recall33 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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