Ventlab HS4051Recalls & reported problems

Ventlab, LLC · .5 LITRE HYPERINFLATION BAG SYSTEM W/ MANOMETER · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483105214), received between Feb 20, 2024 and Feb 20, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical 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.

Reports received per month

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

Most reported problems

Device problems

Mechanical Problem1

Patient problems

Respiratory Insufficiency1

Recent adverse event reports

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

InjuryFeb 20, 2024Mechanical Problem; Mechanical Problem
THE PEEP ON THE MANOMETER WASN'T WORKING CORRECTLY. THE PATIENT WAS PUT ON A VENT.
Patient problems: Respiratory Insufficiency
MAUDE report 18743617 ↗

Device details

UDI-DI	`10889483105214`
Brand	Ventlab
Model	HS4051
Company	Ventlab, LLC
Product code	NHK · Resuscitator,Manual,Non Self-Inflating
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	Mar 29, 2018

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.

Other Resuscitator,Manual,Non Self-Inflating devices

Ventlab HS4011
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5 reports
Ventlab HS4000
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Hyperinflation System 10-55833
Mercury Enterprises, Inc. · Resuscitator,Manual,Non Self-Inflating
1 report

All Resuscitator,Manual,Non Self-Inflating 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
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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