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Ventlab AF5040MBRecalls & reported problems

Ventlab, LLC · AirFlow Adult Resuscitator with B/V Filter, Bag Reservoir, and Mask · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483079126), received between Jul 7, 2023 and Jul 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Integrity Problem1

Patient problems

  • Low Oxygen Saturation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 7, 2023Material Integrity Problem; Material Integrity Problem

    FACE MASKS INSIDE THE KIT ARE FLAT(UNDERINFLATED).

    Patient problems: Low Oxygen Saturation

    MAUDE report 17279423 ↗

Other Ventilator, Emergency, Manual (Resuscitator) devices

All Ventilator, Emergency, Manual (Resuscitator) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.