Hyperinflation System 10-55833Recalls & reported problems

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 10641043558331), received between Sep 13, 2019 and Sep 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Detachment of Device or Device Component1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

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

MalfunctionSep 13, 2019Detachment of Device or Device Component
WHILE PERFORMING POSITIVE PRESSURE VENTILATION (PPV) ON A NEWBORN, THE BAG SPONTANEOUSLY DETACHED FROM THE HUB ON THE FACE MASK. THE PROVIDER HAD TO REATTACH THE BAG IN ORDER TO CONTINUE PPV. THE NEWBORN EVENTUALLY DEVELOPED SPONTANEOUS CRY AND PPV WAS DISCONTINUED. THERE WAS NO HARM TO THE NEWBORN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9024769 ↗

Device details

UDI-DI	`10641043558331`
Brand	Hyperinflation System
Model	10-55833
Company	Mercury Enterprises, Inc.
Product code	NHK · Resuscitator,Manual,Non Self-Inflating
Class	Class 2
FDA submission	K001714
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	May 19, 2020

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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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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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