Ventlab AF3040MBRecalls & reported problems

Ventlab, LLC · AirFlow Infant Resuscitator with 40cm Pop-Off, 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 10889483085783), received between Sep 12, 2025 and Sep 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow 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.

Reports received per month

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

Most reported problems

Device problems

Infusion or Flow Problem1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionSep 12, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED: UNABLE TO OBTAIN CHEST RISE DURING USE BY EXPERIENCED STAFF FOR THE INFANT WHO WAS IN NEED OF URGENT INTUBATION; THE CHILD BAG WAS USED INSTEAD; THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 23045586 ↗

Device details

UDI-DI	`10889483085783`
Brand	Ventlab
Model	AF3040MB
Company	Ventlab, LLC
Product code	BTM · Ventilator, Emergency, Manual (Resuscitator)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 10, 2023

Device type (GMDN): Pulmonary resuscitator, manual, single-use

A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

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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.