LTV 18888-006Recalls & reported problems

Carefusion Corporation · ASSY, LTV1200, W/ ACCESS, JAPAN · Class 2

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

Quick summary

This is a CareFusion LTV ventilator accessory, used in hospital and transport settings to help patients breathe. The 43 FDA reports mostly describe mechanical breakdowns: leaking pressure sensing lines, a broken part inside the unit, dark or missing display dots on the front panel, alarms that stay on, and delivered air or oxygen volumes drifting outside their set limits. One report involved a patient. There were no deaths and one injury. No recalls name this device, and no reports were filed in either of the last two 12-month periods.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 43
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00845873002641), received between Jan 3, 2019 and May 14, 2022 — classified as 1 injury, 42 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (30 reports).

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 Problem30
Tidal Volume Fluctuations6
Improper Flow or Infusion3
Battery Problem2
Display or Visual Feedback Problem1
Infusion or Flow Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions18
No Information13
No Patient Involvement10
No Consequences Or Impact To Patient2

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 14, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 HAS HIGH PRESSURE SENSE LINE LEAKS AND BROKEN ACCUMULATOR. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14403387 ↗
MalfunctionMay 12, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH LAP TOP VENTILATOR 1200 WHERE SOME LED DOTS ARE DARK. FURTHERMORE, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14383467 ↗
MalfunctionMay 12, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH LAP TOP VENTILATOR 1200 WHERE SOME LED DOTS ARE DARK. FURTHERMORE, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14382896 ↗
MalfunctionAug 24, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LTV VENTILATOR PART OF LED WAS DARK. THIS IS FRONT PANEL OVERVIEW - CONTROL SECTION. BREATH RATE. INSP TIME. O2%. SENSITIVITY AND PEEP. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12363396 ↗
MalfunctionAug 13, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED LN VENT OCCURRED IN THIS DEVICE. THERE IS PATIENT INVOLVEMENT ASSOCIATED WITH THE ISSUE REPORTED BUT NO HARM HAPPENED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12319714 ↗
MalfunctionApr 23, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 HAS CONTINUOUS HIGH PEEP (POSITIVE END EXPIRATORY PRESSURE) ALARM. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11712878 ↗
MalfunctionApr 13, 2021Improper Flow or Infusion; Improper Flow or Infusion
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 OXYGEN DOES NOT INCREASE WHEN TURBINE IS RAMPING UP. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11661335 ↗
MalfunctionApr 13, 2021Improper Flow or Infusion; Improper Flow or Infusion
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAPTOP VENTILATOR 1200 DELIVERED VT(TIDAL VOLUME) EXCEEDS HIGH LIMIT. IT WAS MEASURED 560 ML TO HIGH. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11661301 ↗
MalfunctionApr 13, 2021Improper Flow or Infusion; Improper Flow or Infusion
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 OXYGEN DOES NOT INCREASE WHEN TURBINE IS RAMPING UP. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11661255 ↗
MalfunctionFeb 11, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1200 EXPERIENCED TURBINE NOT ROTATING. AS OF THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11318004 ↗
MalfunctionJan 4, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LTV (LAP TOP VENTILATOR) 1200 ALARMED INOPERABLE AND STOPPED WORKING. AT THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11109773 ↗
MalfunctionDec 23, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1200 VENTILATOR IS AUTO CYCLING. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11069553 ↗
MalfunctionDec 21, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED DELIVERED TIDAL VOLUME IS EXCEEDING HIGH LIMIT ON THE LAP TOP VENTILATOR 1200. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11047181 ↗
MalfunctionDec 18, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1200 UNIT STOPPED VENTILATING. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11042191 ↗
MalfunctionOct 19, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1200 WITH NEWLY INSTALLED BATTERY ALARMED RESET (LN VENT). AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10702009 ↗
MalfunctionOct 12, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 UNIT IS GIVING LN ALARM (SHUTDOWN FOR OTHER THAN PRESSING ON/STANDBY) . AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10663397 ↗
MalfunctionOct 9, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE TURBINE DID NOT ROTATE ON LAP TOP VENTILATOR 1200. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10657572 ↗
MalfunctionSep 24, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE PEEP (POSITIVE END-EXPIRATORY PRESSURE) SOLENOID IS UNSTABLE ON LAP TOP VENTILATOR 1200. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10581891 ↗
MalfunctionAug 27, 2020Tidal Volume Fluctuations; Tidal Volume Fluctuations
THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1200 UNIT EXPERIENCED DELIVERED TIDAL VOLUME EXCEEDING THE HIGH LIMIT. THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Information
MAUDE report 10463414 ↗
MalfunctionAug 27, 2020Tidal Volume Fluctuations; Tidal Volume Fluctuations
THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1200 DELIVERED TIDAL VOLUME EXCEEDING THE HIGH LIMIT. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT.
Patient problems: No Information
MAUDE report 10463410 ↗
MalfunctionAug 27, 2020Tidal Volume Fluctuations; Tidal Volume Fluctuations
THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1200 DELIVERED TIDAL VOLUME EXCEEDS THE HIGH LIMIT. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT.
Patient problems: No Information
MAUDE report 10463408 ↗
MalfunctionAug 14, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED LTV 1200 DELIVERED TIDAL VOLUME EXCEEDING THE HIGH LIMIT SET AT 500ML : LOW 450 HIGH 550, MEASURED FAILURE. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Information
MAUDE report 10411530 ↗
MalfunctionAug 14, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE LTV 1200 VENTILATOR DELIVERED TIDAL VOLUME EXCEEDING THE HIGH LIMIT. THE CUSTOMER CLAIMS THAT WHEN SET AT 500ML IT MEASURE 560 FAILURE. AT THIS TIME, PATIENT INVOLVEMENT IS UNKNOWN.
Patient problems: No Information
MAUDE report 10411527 ↗
MalfunctionAug 14, 2020Tidal Volume Fluctuations; Tidal Volume Fluctuations
THE CUSTOMER REPORTED THAT THE DELIVERED TIDAL VOLUME WAS EXCEEDING THE HIGH LIMIT ON LTV1200 UNIT. THE CUSTOMER CONFIRMED THAT WHEN SET AT 500ML IT MEASURED 560ML. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Information
MAUDE report 10411525 ↗
MalfunctionJul 31, 2020Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED THAT LTV 1200 IS DELIVERING HIGH O2 (60% GREATER THAN 72%). AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Information
MAUDE report 10353885 ↗

Device details

UDI-DI	`00845873002641`
Brand	LTV
Model	18888-006
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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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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