LTV 21102-001 (UDI 00845873003778)Recalls & reported problems

Carefusion Corporation · ASSY, LTV1100, W/ ACCESS, ENGLISH · 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 00845873003778), received between Jul 24, 2019 and Jul 24, 2019 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Mechanical Problem1
Volume Accuracy Problem1

Patient problems

No Patient Involvement1

Recent adverse event reports

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

MalfunctionJul 24, 2019Mechanical Problem; Volume Accuracy Problem; Mechanical Problem; Volume Accuracy Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR FAILED TO ACHIEVE THE CORRECT TIDAL VOLUME. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8822714 ↗

Device details

UDI-DI	`00845873003778`
Brand	LTV
Model	21102-001
Company	Carefusion Corporation
Product code	CBK · Ventilator, Continuous, Facility Use
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	Not in Commercial Distribution
Record updated	Jun 6, 2024

Device type (GMDN): Transport electric ventilator

An electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.

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All Ventilator, Continuous, Facility Use devices →

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